Created at Source Raw Value Validated value
Oct. 26, 2020, 8:29 a.m. oms

To be eligible for this study, participants must meet all of the following criteria: 1. Healthy male and female volunteers aged >= 18 to <= 65 years at the time of informed consent. 2. In good health as determined by medical history and PE at Screening and Admission to the CRU. 3. Must have a minimum body weight of >=45 kg and <=100 kg and a BMI between 18 and 30 kg/m2, inclusive, at Screening. 4. Must have clinical laboratory values within normal range as specified by the testing laboratory, unless deemed not clinically significant by the Investigator or their delegate. 5. Negative test for drugs of abuse at Screening and Admission to the CRU. 6. Negative test for alcohol use (breathalyzer) at Screening and Admission to the CRU. 7. Women of childbearing potential must use an acceptable, highly effective double barrier contraception from Screening until study completion, including the follow-up period. Double contraception is defined as a condom AND one other form of the following: a. Established hormonal contraception (oral contraceptive pill, long-acting implantable hormones, injectable hormones). b. A vaginal ring or an IUD). c. Documented evidence of surgical sterilization at least 6 months prior to Screening (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy for women or vasectomy for men [with appropriate post-vasectomy documentation of the absence of sperm in semen] provided the male partner is a sole partner). Women not of childbearing potential must be postmenopausal for >=12 months at Screening. Postmenopausal status will be confirmed through testing of FSH levels >= 40 IU/mL at Screening for amenorrheic female participants. Females who are abstinent from heterosexual intercourse will also be eligible. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not considered highly effective methods of birth control. Participants who practice complete abstinence as part of their usual and preferred lifestyle will be eligible. Female participants who are in same sex relationships are not required to use contraception. WOCBP must have a negative pregnancy test at Screening and prior to administration of the initial dose of study drug and must be willing to have additional pregnancy tests as required throughout the study. Males must be surgically sterile (>30 days since vasectomy with no viable sperm), abstinent, or, if engaged in sexual relations with a WOCBP, his partner must be surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or the participant and his partner must be using an acceptable, highly effective double barrier contraceptive method from Screening until study completion, including the follow-up period. Acceptable methods of contraception include the use of condoms AND the use of an effective contraceptive for the female partner that includes: OCPs, long-acting implantable hormones, injectable hormones, a vaginal ring, or an IUD. Participants with same sex partners (abstinence from penile-vaginal intercourse) are eligible when this is their preferred and usual lifestyle. 8. Male participants must not donate sperm for at least 90 days after the last dose of study drug. 9. Must have the ability and willingness to attend the necessary visits to the CRU. 10. Must be willing and able to provide written informed consent after the nature of the study has been expl

To be eligible for this study, participants must meet all of the following criteria: 1. Healthy male and female volunteers aged >= 18 to <= 65 years at the time of informed consent. 2. In good health as determined by medical history and PE at Screening and Admission to the CRU. 3. Must have a minimum body weight of >=45 kg and <=100 kg and a BMI between 18 and 30 kg/m2, inclusive, at Screening. 4. Must have clinical laboratory values within normal range as specified by the testing laboratory, unless deemed not clinically significant by the Investigator or their delegate. 5. Negative test for drugs of abuse at Screening and Admission to the CRU. 6. Negative test for alcohol use (breathalyzer) at Screening and Admission to the CRU. 7. Women of childbearing potential must use an acceptable, highly effective double barrier contraception from Screening until study completion, including the follow-up period. Double contraception is defined as a condom AND one other form of the following: a. Established hormonal contraception (oral contraceptive pill, long-acting implantable hormones, injectable hormones). b. A vaginal ring or an IUD). c. Documented evidence of surgical sterilization at least 6 months prior to Screening (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy for women or vasectomy for men [with appropriate post-vasectomy documentation of the absence of sperm in semen] provided the male partner is a sole partner). Women not of childbearing potential must be postmenopausal for >=12 months at Screening. Postmenopausal status will be confirmed through testing of FSH levels >= 40 IU/mL at Screening for amenorrheic female participants. Females who are abstinent from heterosexual intercourse will also be eligible. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not considered highly effective methods of birth control. Participants who practice complete abstinence as part of their usual and preferred lifestyle will be eligible. Female participants who are in same sex relationships are not required to use contraception. WOCBP must have a negative pregnancy test at Screening and prior to administration of the initial dose of study drug and must be willing to have additional pregnancy tests as required throughout the study. Males must be surgically sterile (>30 days since vasectomy with no viable sperm), abstinent, or, if engaged in sexual relations with a WOCBP, his partner must be surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or the participant and his partner must be using an acceptable, highly effective double barrier contraceptive method from Screening until study completion, including the follow-up period. Acceptable methods of contraception include the use of condoms AND the use of an effective contraceptive for the female partner that includes: OCPs, long-acting implantable hormones, injectable hormones, a vaginal ring, or an IUD. Participants with same sex partners (abstinence from penile-vaginal intercourse) are eligible when this is their preferred and usual lifestyle. 8. Male participants must not donate sperm for at least 90 days after the last dose of study drug. 9. Must have the ability and willingness to attend the necessary visits to the CRU. 10. Must be willing and able to provide written informed consent after the nature of the study has been expl