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

inclusion criteria: 1. able and willing to provide written informed consent (voluntarily signed by the subject) prior to performing study procedures. 2. females and males 18-60 years of age, inclusive. 3. have a body mass index (bmi) less than or equal to 35.0 kg/m2. 4. women who are either: a) not of childbearing potential: either surgically sterile (at least six weeks post bilateral tubal ligation, bilateral oophorectomy or hysterectomy); or post-menopausal (defined as ≥50 years of age with a history of ≥12 months without menses prior to randomization in the absence of other pathologic or physiologic causes, following cessation of exogenous sex-hormonal treatment); or b) women of childbearing potential (wocbp) who are not planning to be pregnant during the study period and meet all of the following criteria: negative serum pregnancy test (pt) at screening; and negative pt prior to dosing at day 1; and use of a highly effective contraception during the study period: * hormonal contraceptives (e.g., implants, pills, patches) initiated ≥30 days prior to day 1; or * intrauterine device (iud) inserted ≥30 days prior to day 1; or * double barrier type of birth control (e.g., male condom with female diaphragm, male condom with cervical cap). 5. subject understands and agrees to comply with planned study procedures. 6. healthy as determined by the principal investigator based on medical history, physical exam, vital signs, urinalysis, blood chemistry and hematology test results at screening and evidence of no prior exposure to sars-cov-2 (i.e., reverse transcription polymerase chain reaction \[rt-pcr\] negative for sars-cov-2 and negative for sars-cov-2 antibodies) at screening.

inclusion criteria: 1. able and willing to provide written informed consent (voluntarily signed by the subject) prior to performing study procedures. 2. females and males 18-60 years of age, inclusive. 3. have a body mass index (bmi) less than or equal to 35.0 kg/m2. 4. women who are either: a) not of childbearing potential: either surgically sterile (at least six weeks post bilateral tubal ligation, bilateral oophorectomy or hysterectomy); or post-menopausal (defined as ≥50 years of age with a history of ≥12 months without menses prior to randomization in the absence of other pathologic or physiologic causes, following cessation of exogenous sex-hormonal treatment); or b) women of childbearing potential (wocbp) who are not planning to be pregnant during the study period and meet all of the following criteria: negative serum pregnancy test (pt) at screening; and negative pt prior to dosing at day 1; and use of a highly effective contraception during the study period: * hormonal contraceptives (e.g., implants, pills, patches) initiated ≥30 days prior to day 1; or * intrauterine device (iud) inserted ≥30 days prior to day 1; or * double barrier type of birth control (e.g., male condom with female diaphragm, male condom with cervical cap). 5. subject understands and agrees to comply with planned study procedures. 6. healthy as determined by the principal investigator based on medical history, physical exam, vital signs, urinalysis, blood chemistry and hematology test results at screening and evidence of no prior exposure to sars-cov-2 (i.e., reverse transcription polymerase chain reaction \[rt-pcr\] negative for sars-cov-2 and negative for sars-cov-2 antibodies) at screening.

Feb. 3, 2023, 8 p.m. usa

inclusion criteria: able and willing to provide written informed consent (voluntarily signed by the subject) prior to performing study procedures. females and males 18-60 years of age, inclusive. have a body mass index (bmi) less than or equal to 35.0 kg/m2. women who are either: a) not of childbearing potential: either surgically sterile (at least six weeks post bilateral tubal ligation, bilateral oophorectomy or hysterectomy); or post-menopausal (defined as ≥50 years of age with a history of ≥12 months without menses prior to randomization in the absence of other pathologic or physiologic causes, following cessation of exogenous sex-hormonal treatment); or b) women of childbearing potential (wocbp) who are not planning to be pregnant during the study period and meet all of the following criteria: negative serum pregnancy test (pt) at screening; and negative pt prior to dosing at day 1; and use of a highly effective contraception during the study period: hormonal contraceptives (e.g., implants, pills, patches) initiated ≥30 days prior to day 1; or intrauterine device (iud) inserted ≥30 days prior to day 1; or double barrier type of birth control (e.g., male condom with female diaphragm, male condom with cervical cap). subject understands and agrees to comply with planned study procedures. healthy as determined by the principal investigator based on medical history, physical exam, vital signs, urinalysis, blood chemistry and hematology test results at screening and evidence of no prior exposure to sars-cov-2 (i.e., reverse transcription polymerase chain reaction [rt-pcr] negative for sars-cov-2 and negative for sars-cov-2 antibodies) at screening.

inclusion criteria: able and willing to provide written informed consent (voluntarily signed by the subject) prior to performing study procedures. females and males 18-60 years of age, inclusive. have a body mass index (bmi) less than or equal to 35.0 kg/m2. women who are either: a) not of childbearing potential: either surgically sterile (at least six weeks post bilateral tubal ligation, bilateral oophorectomy or hysterectomy); or post-menopausal (defined as ≥50 years of age with a history of ≥12 months without menses prior to randomization in the absence of other pathologic or physiologic causes, following cessation of exogenous sex-hormonal treatment); or b) women of childbearing potential (wocbp) who are not planning to be pregnant during the study period and meet all of the following criteria: negative serum pregnancy test (pt) at screening; and negative pt prior to dosing at day 1; and use of a highly effective contraception during the study period: hormonal contraceptives (e.g., implants, pills, patches) initiated ≥30 days prior to day 1; or intrauterine device (iud) inserted ≥30 days prior to day 1; or double barrier type of birth control (e.g., male condom with female diaphragm, male condom with cervical cap). subject understands and agrees to comply with planned study procedures. healthy as determined by the principal investigator based on medical history, physical exam, vital signs, urinalysis, blood chemistry and hematology test results at screening and evidence of no prior exposure to sars-cov-2 (i.e., reverse transcription polymerase chain reaction [rt-pcr] negative for sars-cov-2 and negative for sars-cov-2 antibodies) at screening.

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

inclusion criteria: able and willing to provide written informed consent (voluntarily signed by the subject) prior to performing study procedures. females and males 18-60 years of age, inclusive. have a body mass index (bmi) less than or equal to 35.0 kg/m2. women who are either: a) not of childbearing potential: either surgically sterile (at least six weeks post bilateral tubal ligation, bilateral oophorectomy or hysterectomy); or post-menopausal (defined as ≥50 years of age with a history of ≥12 months without menses prior to randomization in the absence of other pathologic or physiologic causes, following cessation of exogenous sex-hormonal treatment); or b) women of childbearing potential (wocbp) who are not planning to be pregnant during the study period and meet all of the following criteria: negative serum pregnancy test (pt) at screening; and negative pt prior to dosing at day 1; and use of a highly effective contraception during the study period: hormonal contraceptives (e.g., implants, pills, patches) initiated ≥30 days prior to day 1; or intrauterine device (iud) inserted ≥30 days prior to day 1; or double barrier type of birth control (e.g., male condom with female diaphragm, male condom with cervical cap). subject understands and agrees to comply with planned study procedures. healthy as determined by the principal investigator based on medical history, physical exam, vital signs, urinalysis, blood chemistry and hematology test results at screening and evidence of no prior exposure to sars-cov-2 (i.e., rt-pcr negative for sars-cov-2 and negative for sars-cov-2 antibodies) at screening.

inclusion criteria: able and willing to provide written informed consent (voluntarily signed by the subject) prior to performing study procedures. females and males 18-60 years of age, inclusive. have a body mass index (bmi) less than or equal to 35.0 kg/m2. women who are either: a) not of childbearing potential: either surgically sterile (at least six weeks post bilateral tubal ligation, bilateral oophorectomy or hysterectomy); or post-menopausal (defined as ≥50 years of age with a history of ≥12 months without menses prior to randomization in the absence of other pathologic or physiologic causes, following cessation of exogenous sex-hormonal treatment); or b) women of childbearing potential (wocbp) who are not planning to be pregnant during the study period and meet all of the following criteria: negative serum pregnancy test (pt) at screening; and negative pt prior to dosing at day 1; and use of a highly effective contraception during the study period: hormonal contraceptives (e.g., implants, pills, patches) initiated ≥30 days prior to day 1; or intrauterine device (iud) inserted ≥30 days prior to day 1; or double barrier type of birth control (e.g., male condom with female diaphragm, male condom with cervical cap). subject understands and agrees to comply with planned study procedures. healthy as determined by the principal investigator based on medical history, physical exam, vital signs, urinalysis, blood chemistry and hematology test results at screening and evidence of no prior exposure to sars-cov-2 (i.e., rt-pcr negative for sars-cov-2 and negative for sars-cov-2 antibodies) at screening.

Dec. 12, 2020, 12:31 a.m. usa

inclusion criteria: 1. able and willing to provide written informed consent (voluntarily signed by the subject) prior to performing study procedures. 2. females and males 18-60 years of age, inclusive. 3. have a body mass index (bmi) less than or equal to 35.0 kg/m2. 4. women who are either: a) not of childbearing potential: either surgically sterile (at least six weeks post bilateral tubal ligation, bilateral oophorectomy or hysterectomy); or post-menopausal (defined as ≥50 years of age with a history of ≥12 months without menses prior to randomization in the absence of other pathologic or physiologic causes, following cessation of exogenous sex-hormonal treatment); or b) women of childbearing potential (wocbp) who are not planning to be pregnant during the study period and meet all of the following criteria: negative serum pregnancy test (pt) at screening; and negative pt prior to dosing at day 1; and use of a highly effective contraception during the study period: - hormonal contraceptives (e.g., implants, pills, patches) initiated ≥30 days prior to day 1; or - intrauterine device (iud) inserted ≥30 days prior to day 1; or - double barrier type of birth control (e.g., male condom with female diaphragm, male condom with cervical cap). 5. subject understands and agrees to comply with planned study procedures. 6. healthy as determined by the principal investigator based on medical history, physical exam, vital signs, urinalysis, blood chemistry and hematology test results at screening and evidence of no prior exposure to sars-cov-2 (i.e., rt-pcr negative for sars-cov-2 and negative for sars-cov-2 antibodies) at screening.

inclusion criteria: 1. able and willing to provide written informed consent (voluntarily signed by the subject) prior to performing study procedures. 2. females and males 18-60 years of age, inclusive. 3. have a body mass index (bmi) less than or equal to 35.0 kg/m2. 4. women who are either: a) not of childbearing potential: either surgically sterile (at least six weeks post bilateral tubal ligation, bilateral oophorectomy or hysterectomy); or post-menopausal (defined as ≥50 years of age with a history of ≥12 months without menses prior to randomization in the absence of other pathologic or physiologic causes, following cessation of exogenous sex-hormonal treatment); or b) women of childbearing potential (wocbp) who are not planning to be pregnant during the study period and meet all of the following criteria: negative serum pregnancy test (pt) at screening; and negative pt prior to dosing at day 1; and use of a highly effective contraception during the study period: - hormonal contraceptives (e.g., implants, pills, patches) initiated ≥30 days prior to day 1; or - intrauterine device (iud) inserted ≥30 days prior to day 1; or - double barrier type of birth control (e.g., male condom with female diaphragm, male condom with cervical cap). 5. subject understands and agrees to comply with planned study procedures. 6. healthy as determined by the principal investigator based on medical history, physical exam, vital signs, urinalysis, blood chemistry and hematology test results at screening and evidence of no prior exposure to sars-cov-2 (i.e., rt-pcr negative for sars-cov-2 and negative for sars-cov-2 antibodies) at screening.