Created at Source Raw Value Validated value
June 25, 2024, noon usa

key inclusion criteria: each participant must meet all of the following criteria during the screening period and at day 1, unless noted otherwise, to be enrolled in this study: 1. male or female, 18 years of age or older at the time of consent (screening visit, day 0). for part b, participants must have been previously enrolled in the mrna-1273 p201 study. 2. understands and agrees to comply with the study procedures and provides written informed consent. 3. according to the assessment of the investigator, is in good general health and can comply with study procedures. 4. female participants of nonchildbearing potential may be enrolled in the study. nonchildbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as amenorrhea for ≥12 consecutive months prior to screening (day 0) without an alternative medical cause). a follicle-stimulating hormone (fsh) level may be measured at the discretion of the investigator to confirm postmenopausal status. 5. female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria: * has a negative pregnancy test at screening (day 0) and on the day of the first injection (day 1). * has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection (day 1). * has agreed to continue adequate contraception through 3 months following the second injection (day 29). * is not currently breastfeeding. adequate female contraception is defined as consistent and correct use of a food and drug administration (fda) approved contraceptive method in accordance with the product label. for example: * barrier method (such as condoms, diaphragm, or cervical cap) used in conjunction with spermicide * intrauterine device * prescription hormonal contraceptive taken or administered via oral (pill), transdermal (patch), subdermal, or im route * sterilization of a female participant's monogamous male partner prior to entry into the study note: periodic abstinence (for example, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. 6. male participants engaging in activity that could result in pregnancy of sexual partners must agree to practice adequate contraception from the time of the first injection and through 3 months after the last injection. adequate contraception for male participants is defined as: * monogamous relationship with a female partner using an intrauterine device or hormonal contraception (described above) * use of barrier methods and spermicide * history of surgical sterilization * male participants with partners who have become pregnant prior to screening are eligible to participate in the study. additional key inclusion criteria for part c 1. participants must have been previously enrolled in the mrna-1273-p301 study and must have received 2 doses of mrna-1273 in part a, has been unblinded and aware of their actual treatment in study mrna-1273-p301, must have been compliant in study mrna-1273-p301 (was not withdrawn or discontinued early), and has been at least 6 months since their second dose in study mrna-1273-p301 prior to enrollment in this part. key

key inclusion criteria: each participant must meet all of the following criteria during the screening period and at day 1, unless noted otherwise, to be enrolled in this study: 1. male or female, 18 years of age or older at the time of consent (screening visit, day 0). for part b, participants must have been previously enrolled in the mrna-1273 p201 study. 2. understands and agrees to comply with the study procedures and provides written informed consent. 3. according to the assessment of the investigator, is in good general health and can comply with study procedures. 4. female participants of nonchildbearing potential may be enrolled in the study. nonchildbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as amenorrhea for ≥12 consecutive months prior to screening (day 0) without an alternative medical cause). a follicle-stimulating hormone (fsh) level may be measured at the discretion of the investigator to confirm postmenopausal status. 5. female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria: * has a negative pregnancy test at screening (day 0) and on the day of the first injection (day 1). * has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection (day 1). * has agreed to continue adequate contraception through 3 months following the second injection (day 29). * is not currently breastfeeding. adequate female contraception is defined as consistent and correct use of a food and drug administration (fda) approved contraceptive method in accordance with the product label. for example: * barrier method (such as condoms, diaphragm, or cervical cap) used in conjunction with spermicide * intrauterine device * prescription hormonal contraceptive taken or administered via oral (pill), transdermal (patch), subdermal, or im route * sterilization of a female participant's monogamous male partner prior to entry into the study note: periodic abstinence (for example, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. 6. male participants engaging in activity that could result in pregnancy of sexual partners must agree to practice adequate contraception from the time of the first injection and through 3 months after the last injection. adequate contraception for male participants is defined as: * monogamous relationship with a female partner using an intrauterine device or hormonal contraception (described above) * use of barrier methods and spermicide * history of surgical sterilization * male participants with partners who have become pregnant prior to screening are eligible to participate in the study. additional key inclusion criteria for part c 1. participants must have been previously enrolled in the mrna-1273-p301 study and must have received 2 doses of mrna-1273 in part a, has been unblinded and aware of their actual treatment in study mrna-1273-p301, must have been compliant in study mrna-1273-p301 (was not withdrawn or discontinued early), and has been at least 6 months since their second dose in study mrna-1273-p301 prior to enrollment in this part. key

Nov. 16, 2021, 6:30 p.m. usa

key inclusion criteria: each participant must meet all of the following criteria during the screening period and at day 1, unless noted otherwise, to be enrolled in this study: male or female, 18 years of age or older at the time of consent (screening visit, day 0). for part b, participants must have been previously enrolled in the mrna-1273 p201 study. understands and agrees to comply with the study procedures and provides written informed consent. according to the assessment of the investigator, is in good general health and can comply with study procedures. female participants of nonchildbearing potential may be enrolled in the study. nonchildbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as amenorrhea for ≥12 consecutive months prior to screening (day 0) without an alternative medical cause). a follicle-stimulating hormone (fsh) level may be measured at the discretion of the investigator to confirm postmenopausal status. female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria: has a negative pregnancy test at screening (day 0) and on the day of the first injection (day 1). has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection (day 1). has agreed to continue adequate contraception through 3 months following the second injection (day 29). is not currently breastfeeding. adequate female contraception is defined as consistent and correct use of a food and drug administration (fda) approved contraceptive method in accordance with the product label. for example: barrier method (such as condoms, diaphragm, or cervical cap) used in conjunction with spermicide intrauterine device prescription hormonal contraceptive taken or administered via oral (pill), transdermal (patch), subdermal, or im route sterilization of a female participant's monogamous male partner prior to entry into the study note: periodic abstinence (for example, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. male participants engaging in activity that could result in pregnancy of sexual partners must agree to practice adequate contraception from the time of the first injection and through 3 months after the last injection. adequate contraception for male participants is defined as: monogamous relationship with a female partner using an intrauterine device or hormonal contraception (described above) use of barrier methods and spermicide history of surgical sterilization male participants with partners who have become pregnant prior to screening are eligible to participate in the study. additional key inclusion criteria for part c 1. participants must have been previously enrolled in the mrna-1273-p301 study and must have received 2 doses of mrna-1273 in part a, has been unblinded and aware of their actual treatment in study mrna-1273-p301, must have been compliant in study mrna-1273-p301 (was not withdrawn or discontinued early), and has been at least 6 months since their second dose in study mrna-1273-p301 prior to enrollment in this part. key

key inclusion criteria: each participant must meet all of the following criteria during the screening period and at day 1, unless noted otherwise, to be enrolled in this study: male or female, 18 years of age or older at the time of consent (screening visit, day 0). for part b, participants must have been previously enrolled in the mrna-1273 p201 study. understands and agrees to comply with the study procedures and provides written informed consent. according to the assessment of the investigator, is in good general health and can comply with study procedures. female participants of nonchildbearing potential may be enrolled in the study. nonchildbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as amenorrhea for ≥12 consecutive months prior to screening (day 0) without an alternative medical cause). a follicle-stimulating hormone (fsh) level may be measured at the discretion of the investigator to confirm postmenopausal status. female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria: has a negative pregnancy test at screening (day 0) and on the day of the first injection (day 1). has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection (day 1). has agreed to continue adequate contraception through 3 months following the second injection (day 29). is not currently breastfeeding. adequate female contraception is defined as consistent and correct use of a food and drug administration (fda) approved contraceptive method in accordance with the product label. for example: barrier method (such as condoms, diaphragm, or cervical cap) used in conjunction with spermicide intrauterine device prescription hormonal contraceptive taken or administered via oral (pill), transdermal (patch), subdermal, or im route sterilization of a female participant's monogamous male partner prior to entry into the study note: periodic abstinence (for example, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. male participants engaging in activity that could result in pregnancy of sexual partners must agree to practice adequate contraception from the time of the first injection and through 3 months after the last injection. adequate contraception for male participants is defined as: monogamous relationship with a female partner using an intrauterine device or hormonal contraception (described above) use of barrier methods and spermicide history of surgical sterilization male participants with partners who have become pregnant prior to screening are eligible to participate in the study. additional key inclusion criteria for part c 1. participants must have been previously enrolled in the mrna-1273-p301 study and must have received 2 doses of mrna-1273 in part a, has been unblinded and aware of their actual treatment in study mrna-1273-p301, must have been compliant in study mrna-1273-p301 (was not withdrawn or discontinued early), and has been at least 6 months since their second dose in study mrna-1273-p301 prior to enrollment in this part. key

March 26, 2021, 12:31 a.m. usa

key inclusion criteria: each participant must meet all of the following criteria during the screening period and at day 1, unless noted otherwise, to be enrolled in this study: 1. male or female, 18 years of age or older at the time of consent (screening visit, day 0). for part b, participants must have been previously enrolled in the mrna-1273 p201 study. 2. understands and agrees to comply with the study procedures and provides written informed consent. 3. according to the assessment of the investigator, is in good general health and can comply with study procedures. 4. female participants of nonchildbearing potential may be enrolled in the study. nonchildbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as amenorrhea for ≥12 consecutive months prior to screening (day 0) without an alternative medical cause). a follicle-stimulating hormone (fsh) level may be measured at the discretion of the investigator to confirm postmenopausal status. 5. female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria: - has a negative pregnancy test at screening (day 0) and on the day of the first injection (day 1). - has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection (day 1). - has agreed to continue adequate contraception through 3 months following the second injection (day 29). - is not currently breastfeeding. adequate female contraception is defined as consistent and correct use of a food and drug administration (fda) approved contraceptive method in accordance with the product label. for example: - barrier method (such as condoms, diaphragm, or cervical cap) used in conjunction with spermicide - intrauterine device - prescription hormonal contraceptive taken or administered via oral (pill), transdermal (patch), subdermal, or im route - sterilization of a female participant's monogamous male partner prior to entry into the study note: periodic abstinence (for example, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. 6. male participants engaging in activity that could result in pregnancy of sexual partners must agree to practice adequate contraception from the time of the first injection and through 3 months after the last injection. adequate contraception for male participants is defined as: - monogamous relationship with a female partner using an intrauterine device or hormonal contraception (described above) - use of barrier methods and spermicide - history of surgical sterilization - male participants with partners who have become pregnant prior to screening are eligible to participate in the study. additional key inclusion criteria for part c 1. participants must have been previously enrolled in the mrna-1273-p301 study and must have received 2 doses of mrna-1273 in part a, has been unblinded and aware of their actual treatment in study mrna-1273-p301, must have been compliant in study mrna-1273-p301 (was not withdrawn or discontinued early), and has been at least 6 months since their second dose in study mrna-1273-p301 prior to enrollment in this part. key

key inclusion criteria: each participant must meet all of the following criteria during the screening period and at day 1, unless noted otherwise, to be enrolled in this study: 1. male or female, 18 years of age or older at the time of consent (screening visit, day 0). for part b, participants must have been previously enrolled in the mrna-1273 p201 study. 2. understands and agrees to comply with the study procedures and provides written informed consent. 3. according to the assessment of the investigator, is in good general health and can comply with study procedures. 4. female participants of nonchildbearing potential may be enrolled in the study. nonchildbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as amenorrhea for ≥12 consecutive months prior to screening (day 0) without an alternative medical cause). a follicle-stimulating hormone (fsh) level may be measured at the discretion of the investigator to confirm postmenopausal status. 5. female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria: - has a negative pregnancy test at screening (day 0) and on the day of the first injection (day 1). - has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection (day 1). - has agreed to continue adequate contraception through 3 months following the second injection (day 29). - is not currently breastfeeding. adequate female contraception is defined as consistent and correct use of a food and drug administration (fda) approved contraceptive method in accordance with the product label. for example: - barrier method (such as condoms, diaphragm, or cervical cap) used in conjunction with spermicide - intrauterine device - prescription hormonal contraceptive taken or administered via oral (pill), transdermal (patch), subdermal, or im route - sterilization of a female participant's monogamous male partner prior to entry into the study note: periodic abstinence (for example, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. 6. male participants engaging in activity that could result in pregnancy of sexual partners must agree to practice adequate contraception from the time of the first injection and through 3 months after the last injection. adequate contraception for male participants is defined as: - monogamous relationship with a female partner using an intrauterine device or hormonal contraception (described above) - use of barrier methods and spermicide - history of surgical sterilization - male participants with partners who have become pregnant prior to screening are eligible to participate in the study. additional key inclusion criteria for part c 1. participants must have been previously enrolled in the mrna-1273-p301 study and must have received 2 doses of mrna-1273 in part a, has been unblinded and aware of their actual treatment in study mrna-1273-p301, must have been compliant in study mrna-1273-p301 (was not withdrawn or discontinued early), and has been at least 6 months since their second dose in study mrna-1273-p301 prior to enrollment in this part. key

Feb. 13, 2021, 12:31 a.m. usa

inclusion criteria: each participant must meet all of the following criteria during the screening period and at day 1, unless noted otherwise, to be enrolled in this study: 1. male or female, 18 years of age or older at the time of consent (screening visit, day 0). for part b, participants must have been previously enrolled in the mrna-1273 p201 study. 2. understands and agrees to comply with the study procedures and provides written informed consent. 3. according to the assessment of the investigator, is in good general health and can comply with study procedures. 4. female participants of nonchildbearing potential may be enrolled in the study. nonchildbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as amenorrhea for ≥12 consecutive months prior to screening (day 0) without an alternative medical cause). a follicle-stimulating hormone (fsh) level may be measured at the discretion of the investigator to confirm postmenopausal status. 5. female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria: - has a negative pregnancy test at screening (day 0) and on the day of the first injection (day 1). - has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection (day 1). - has agreed to continue adequate contraception through 3 months following the second injection (day 29). - is not currently breastfeeding. adequate female contraception is defined as consistent and correct use of a food and drug administration (fda) approved contraceptive method in accordance with the product label. for example: - barrier method (such as condoms, diaphragm, or cervical cap) used in conjunction with spermicide - intrauterine device - prescription hormonal contraceptive taken or administered via oral (pill), transdermal (patch), subdermal, or im route - sterilization of a female participant's monogamous male partner prior to entry into the study note: periodic abstinence (for example, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. 6. male participants engaging in activity that could result in pregnancy of sexual partners must agree to practice adequate contraception from the time of the first injection and through 3 months after the last injection. adequate contraception for male participants is defined as: - monogamous relationship with a female partner using an intrauterine device or hormonal contraception (described above) - use of barrier methods and spermicide - history of surgical sterilization - male participants with partners who have become pregnant prior to screening are eligible to participate in the study.

inclusion criteria: each participant must meet all of the following criteria during the screening period and at day 1, unless noted otherwise, to be enrolled in this study: 1. male or female, 18 years of age or older at the time of consent (screening visit, day 0). for part b, participants must have been previously enrolled in the mrna-1273 p201 study. 2. understands and agrees to comply with the study procedures and provides written informed consent. 3. according to the assessment of the investigator, is in good general health and can comply with study procedures. 4. female participants of nonchildbearing potential may be enrolled in the study. nonchildbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as amenorrhea for ≥12 consecutive months prior to screening (day 0) without an alternative medical cause). a follicle-stimulating hormone (fsh) level may be measured at the discretion of the investigator to confirm postmenopausal status. 5. female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria: - has a negative pregnancy test at screening (day 0) and on the day of the first injection (day 1). - has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection (day 1). - has agreed to continue adequate contraception through 3 months following the second injection (day 29). - is not currently breastfeeding. adequate female contraception is defined as consistent and correct use of a food and drug administration (fda) approved contraceptive method in accordance with the product label. for example: - barrier method (such as condoms, diaphragm, or cervical cap) used in conjunction with spermicide - intrauterine device - prescription hormonal contraceptive taken or administered via oral (pill), transdermal (patch), subdermal, or im route - sterilization of a female participant's monogamous male partner prior to entry into the study note: periodic abstinence (for example, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. 6. male participants engaging in activity that could result in pregnancy of sexual partners must agree to practice adequate contraception from the time of the first injection and through 3 months after the last injection. adequate contraception for male participants is defined as: - monogamous relationship with a female partner using an intrauterine device or hormonal contraception (described above) - use of barrier methods and spermicide - history of surgical sterilization - male participants with partners who have become pregnant prior to screening are eligible to participate in the study.

Jan. 29, 2021, 12:31 a.m. usa

inclusion criteria: each participant must meet all of the following criteria during the screening period and at day 1, unless noted otherwise, to be enrolled in this study: 1. male or female, 18 years of age or older at the time of consent (screening visit, day 0). 2. understands and agrees to comply with the study procedures and provides written informed consent. 3. according to the assessment of the investigator, is in good general health and can comply with study procedures. 4. body mass index (bmi) of 18 kilograms/meter (kg/m)^2 to 30 kg/m^2 (inclusive) at the screening visit (day 0). 5. female participants of nonchildbearing potential may be enrolled in the study. nonchildbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as amenorrhea for ≥12 consecutive months prior to screening (day 0) without an alternative medical cause). a follicle-stimulating hormone (fsh) level may be measured at the discretion of the investigator to confirm postmenopausal status. 6. female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria: - has a negative pregnancy test at screening (day 0) and on the day of the first injection (day 1). - has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection (day 1). - has agreed to continue adequate contraception through 3 months following the second injection (day 29). - is not currently breastfeeding. adequate female contraception is defined as consistent and correct use of a food and drug administration (fda) approved contraceptive method in accordance with the product label. for example: - barrier method (such as condoms, diaphragm, or cervical cap) used in conjunction with spermicide - intrauterine device - prescription hormonal contraceptive taken or administered via oral (pill), transdermal (patch), subdermal, or intramuscular (im) route - sterilization of a female participant's monogamous male partner prior to entry into the study note: periodic abstinence (for example, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. 7. male participants engaging in activity that could result in pregnancy of sexual partners must agree to practice adequate contraception from the time of the first injection and through 3 months after the last injection. adequate contraception for male participants is defined as: - monogamous relationship with a female partner using an intrauterine device or hormonal contraception (described above) - use of barrier methods and spermicide - history of surgical sterilization - male participants with partners who have become pregnant prior to screening are eligible to participate in the study.

inclusion criteria: each participant must meet all of the following criteria during the screening period and at day 1, unless noted otherwise, to be enrolled in this study: 1. male or female, 18 years of age or older at the time of consent (screening visit, day 0). 2. understands and agrees to comply with the study procedures and provides written informed consent. 3. according to the assessment of the investigator, is in good general health and can comply with study procedures. 4. body mass index (bmi) of 18 kilograms/meter (kg/m)^2 to 30 kg/m^2 (inclusive) at the screening visit (day 0). 5. female participants of nonchildbearing potential may be enrolled in the study. nonchildbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as amenorrhea for ≥12 consecutive months prior to screening (day 0) without an alternative medical cause). a follicle-stimulating hormone (fsh) level may be measured at the discretion of the investigator to confirm postmenopausal status. 6. female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria: - has a negative pregnancy test at screening (day 0) and on the day of the first injection (day 1). - has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection (day 1). - has agreed to continue adequate contraception through 3 months following the second injection (day 29). - is not currently breastfeeding. adequate female contraception is defined as consistent and correct use of a food and drug administration (fda) approved contraceptive method in accordance with the product label. for example: - barrier method (such as condoms, diaphragm, or cervical cap) used in conjunction with spermicide - intrauterine device - prescription hormonal contraceptive taken or administered via oral (pill), transdermal (patch), subdermal, or intramuscular (im) route - sterilization of a female participant's monogamous male partner prior to entry into the study note: periodic abstinence (for example, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. 7. male participants engaging in activity that could result in pregnancy of sexual partners must agree to practice adequate contraception from the time of the first injection and through 3 months after the last injection. adequate contraception for male participants is defined as: - monogamous relationship with a female partner using an intrauterine device or hormonal contraception (described above) - use of barrier methods and spermicide - history of surgical sterilization - male participants with partners who have become pregnant prior to screening are eligible to participate in the study.

Oct. 26, 2020, 11:31 p.m. usa

inclusion criteria: each participant must meet all of the following criteria during the screening period and at day 1, unless noted otherwise, to be enrolled in this study: 1. male or female, 18 years of age or older at the time of consent (screening visit, day 0). 2. understands and agrees to comply with the study procedures and provides written informed consent. 3. according to the assessment of the investigator, is in good general health and can comply with study procedures. 4. body mass index (bmi) of 18 kg/m2 to 30 kg/m2 (inclusive) at the screening visit (day 0). 5. female participants of nonchildbearing potential may be enrolled in the study. nonchildbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as amenorrhea for ≥ 12 consecutive months prior to screening (day 0) without an alternative medical cause). a follicle-stimulating hormone (fsh) level may be measured at the discretion of the investigator to confirm postmenopausal status. 6. female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria: - has a negative pregnancy test at screening (day 0) and on the day of the first injection (day 1). - has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection (day 1). - has agreed to continue adequate contraception through 3 months following the second injection (day 29). - is not currently breastfeeding. adequate female contraception is defined as consistent and correct use of a food and drug administration (fda) approved contraceptive method in accordance with the product label. for example: - barrier method (such as condoms, diaphragm, or cervical cap) used in conjunction with spermicide - intrauterine device - prescription hormonal contraceptive taken or administered via oral (pill), transdermal (patch), subdermal, or im route - sterilization of a female participant's monogamous male partner prior to entry into the study note: periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. 7. male participants engaging in activity that could result in pregnancy of sexual partners must agree to practice adequate contraception from the time of the first injection and through 3 months after the last injection. adequate contraception for male participants is defined as: - monogamous relationship with a female partner using an intrauterine device or hormonal contraception (described above) - use of barrier methods and spermicide - history of surgical sterilization - male participants with partners who have become pregnant prior to screening are eligible to participate in the study.

inclusion criteria: each participant must meet all of the following criteria during the screening period and at day 1, unless noted otherwise, to be enrolled in this study: 1. male or female, 18 years of age or older at the time of consent (screening visit, day 0). 2. understands and agrees to comply with the study procedures and provides written informed consent. 3. according to the assessment of the investigator, is in good general health and can comply with study procedures. 4. body mass index (bmi) of 18 kg/m2 to 30 kg/m2 (inclusive) at the screening visit (day 0). 5. female participants of nonchildbearing potential may be enrolled in the study. nonchildbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as amenorrhea for ≥ 12 consecutive months prior to screening (day 0) without an alternative medical cause). a follicle-stimulating hormone (fsh) level may be measured at the discretion of the investigator to confirm postmenopausal status. 6. female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria: - has a negative pregnancy test at screening (day 0) and on the day of the first injection (day 1). - has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first injection (day 1). - has agreed to continue adequate contraception through 3 months following the second injection (day 29). - is not currently breastfeeding. adequate female contraception is defined as consistent and correct use of a food and drug administration (fda) approved contraceptive method in accordance with the product label. for example: - barrier method (such as condoms, diaphragm, or cervical cap) used in conjunction with spermicide - intrauterine device - prescription hormonal contraceptive taken or administered via oral (pill), transdermal (patch), subdermal, or im route - sterilization of a female participant's monogamous male partner prior to entry into the study note: periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. 7. male participants engaging in activity that could result in pregnancy of sexual partners must agree to practice adequate contraception from the time of the first injection and through 3 months after the last injection. adequate contraception for male participants is defined as: - monogamous relationship with a female partner using an intrauterine device or hormonal contraception (described above) - use of barrier methods and spermicide - history of surgical sterilization - male participants with partners who have become pregnant prior to screening are eligible to participate in the study.