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

inclusion criteria: 1. subjects aged 18 to 60 years old (inclusive) at the time of informed consent who are in good general health in the opinion of the investigator. 2. at screening visit, subjects with a body mass index (bmi) \> 18.5 kg/m2 or ≤ 30.0 kg/m2. 3. subjects without known history of sars-cov-2 infection or known close contact with anyone with laboratory-confirmed sars-cov-2 infection or covid-19 within 2 weeks prior to the first dosing. 4. subjects are willing and able to give informed consent prior to any screening procedure conducting and to comply with study procedures. 5. female subjects of childbearing potential (defined as any female who has experienced menarche and who is not surgically sterile \[ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy\] or postmenopausal \[defined as amenorrhea at least 12 consecutive months or documented plasma follicle-stimulating hormone level ≥40 milli-international unit (miu)/ml\]) must agree to be heterosexually inactive from at least 21 days prior to the screening visit and through 6 months (defined as 24 weeks) after the last dosing or agree to consistently use any of the following methods of contraception from at least 21 days prior to the screening visit and through 6 months (defined as 24 weeks) after the last dosing: * condoms (male or female) with spermicide (if acceptable in country) * diaphragm with spermicide * cervical cap with spermicide * intrauterine device * oral or patch contraceptives * norplant®, depo-provera®, or other in country regulatory-approved contraceptive method that is designed to protect against pregnancy * abstinence, as a form of contraception, is acceptable

inclusion criteria: 1. subjects aged 18 to 60 years old (inclusive) at the time of informed consent who are in good general health in the opinion of the investigator. 2. at screening visit, subjects with a body mass index (bmi) \> 18.5 kg/m2 or ≤ 30.0 kg/m2. 3. subjects without known history of sars-cov-2 infection or known close contact with anyone with laboratory-confirmed sars-cov-2 infection or covid-19 within 2 weeks prior to the first dosing. 4. subjects are willing and able to give informed consent prior to any screening procedure conducting and to comply with study procedures. 5. female subjects of childbearing potential (defined as any female who has experienced menarche and who is not surgically sterile \[ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy\] or postmenopausal \[defined as amenorrhea at least 12 consecutive months or documented plasma follicle-stimulating hormone level ≥40 milli-international unit (miu)/ml\]) must agree to be heterosexually inactive from at least 21 days prior to the screening visit and through 6 months (defined as 24 weeks) after the last dosing or agree to consistently use any of the following methods of contraception from at least 21 days prior to the screening visit and through 6 months (defined as 24 weeks) after the last dosing: * condoms (male or female) with spermicide (if acceptable in country) * diaphragm with spermicide * cervical cap with spermicide * intrauterine device * oral or patch contraceptives * norplant®, depo-provera®, or other in country regulatory-approved contraceptive method that is designed to protect against pregnancy * abstinence, as a form of contraception, is acceptable

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

inclusion criteria: subjects aged 18 to 60 years old (inclusive) at the time of informed consent who are in good general health in the opinion of the investigator. at screening visit, subjects with a body mass index (bmi) > 18.5 kg/m2 or ≤ 30.0 kg/m2. subjects without known history of sars-cov-2 infection or known close contact with anyone with laboratory-confirmed sars-cov-2 infection or covid-19 within 2 weeks prior to the first dosing. subjects are willing and able to give informed consent prior to any screening procedure conducting and to comply with study procedures. female subjects of childbearing potential (defined as any female who has experienced menarche and who is not surgically sterile [ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months or documented plasma follicle-stimulating hormone level ≥40 milli-international unit (miu)/ml]) must agree to be heterosexually inactive from at least 21 days prior to the screening visit and through 6 months (defined as 24 weeks) after the last dosing or agree to consistently use any of the following methods of contraception from at least 21 days prior to the screening visit and through 6 months (defined as 24 weeks) after the last dosing: condoms (male or female) with spermicide (if acceptable in country) diaphragm with spermicide cervical cap with spermicide intrauterine device oral or patch contraceptives norplant®, depo-provera®, or other in country regulatory-approved contraceptive method that is designed to protect against pregnancy abstinence, as a form of contraception, is acceptable

inclusion criteria: subjects aged 18 to 60 years old (inclusive) at the time of informed consent who are in good general health in the opinion of the investigator. at screening visit, subjects with a body mass index (bmi) > 18.5 kg/m2 or ≤ 30.0 kg/m2. subjects without known history of sars-cov-2 infection or known close contact with anyone with laboratory-confirmed sars-cov-2 infection or covid-19 within 2 weeks prior to the first dosing. subjects are willing and able to give informed consent prior to any screening procedure conducting and to comply with study procedures. female subjects of childbearing potential (defined as any female who has experienced menarche and who is not surgically sterile [ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months or documented plasma follicle-stimulating hormone level ≥40 milli-international unit (miu)/ml]) must agree to be heterosexually inactive from at least 21 days prior to the screening visit and through 6 months (defined as 24 weeks) after the last dosing or agree to consistently use any of the following methods of contraception from at least 21 days prior to the screening visit and through 6 months (defined as 24 weeks) after the last dosing: condoms (male or female) with spermicide (if acceptable in country) diaphragm with spermicide cervical cap with spermicide intrauterine device oral or patch contraceptives norplant®, depo-provera®, or other in country regulatory-approved contraceptive method that is designed to protect against pregnancy abstinence, as a form of contraception, is acceptable

Nov. 4, 2021, 1:30 p.m. usa

inclusion criteria: 1. subjects aged 18 to 60 years old (inclusive) at the time of informed consent who are in good general health in the opinion of the investigator. 2. at screening visit, subjects with a body mass index (bmi) > 18.5 kg/m2 or ≤ 30.0 kg/m2. 3. subjects without known history of sars-cov-2 infection or known close contact with anyone with laboratory-confirmed sars-cov-2 infection or covid-19 within 2 weeks prior to the first dosing. 4. subjects are willing and able to give informed consent prior to any screening procedure conducting and to comply with study procedures. 5. female subjects of childbearing potential (defined as any female who has experienced menarche and who is not surgically sterile [ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months or documented plasma follicle-stimulating hormone level ≥40 milli-international unit (miu)/ml]) must agree to be heterosexually inactive from at least 21 days prior to the screening visit and through 6 months (defined as 24 weeks) after the last dosing or agree to consistently use any of the following methods of contraception from at least 21 days prior to the screening visit and through 6 months (defined as 24 weeks) after the last dosing: - condoms (male or female) with spermicide (if acceptable in country) - diaphragm with spermicide - cervical cap with spermicide - intrauterine device - oral or patch contraceptives - norplant®, depo-provera®, or other in country regulatory-approved contraceptive method that is designed to protect against pregnancy - abstinence, as a form of contraception, is acceptable

inclusion criteria: 1. subjects aged 18 to 60 years old (inclusive) at the time of informed consent who are in good general health in the opinion of the investigator. 2. at screening visit, subjects with a body mass index (bmi) > 18.5 kg/m2 or ≤ 30.0 kg/m2. 3. subjects without known history of sars-cov-2 infection or known close contact with anyone with laboratory-confirmed sars-cov-2 infection or covid-19 within 2 weeks prior to the first dosing. 4. subjects are willing and able to give informed consent prior to any screening procedure conducting and to comply with study procedures. 5. female subjects of childbearing potential (defined as any female who has experienced menarche and who is not surgically sterile [ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months or documented plasma follicle-stimulating hormone level ≥40 milli-international unit (miu)/ml]) must agree to be heterosexually inactive from at least 21 days prior to the screening visit and through 6 months (defined as 24 weeks) after the last dosing or agree to consistently use any of the following methods of contraception from at least 21 days prior to the screening visit and through 6 months (defined as 24 weeks) after the last dosing: - condoms (male or female) with spermicide (if acceptable in country) - diaphragm with spermicide - cervical cap with spermicide - intrauterine device - oral or patch contraceptives - norplant®, depo-provera®, or other in country regulatory-approved contraceptive method that is designed to protect against pregnancy - abstinence, as a form of contraception, is acceptable