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 participant) prior to performing study procedures. 2. females and males 18-59 years of age. 3. have a body mass index (bmi) less than or equal to 35.0 kg/m\^2 4. healthy, based on medical history (no chronic disease, no chronic therapy, no ongoing acute condition within four weeks prior to dosing), normal physical examination (no clinically significant findings in the opinion of the investigator), and screening laboratory assessments (no clinically significant findings in the opinion of the investigator). 5. no clinical symptoms suspicious for covid-19 infection, as well as sars-cov-2 immunoglobulin m (igm) antibody negative and no laboratory evidence of current sars-cov-2 infection (i.e., reverse transcription polymerase chain reaction (rt-pcr) negative for sars-cov-2) at screening. 6. females must not be pregnant, or trying to become pregnant as demonstrated by either of the following a or b: a. not of childbearing potential: surgically sterile (at least six weeks post bilateral salpingectomy, bilateral oophorectomy, or hysterectomy); or post-menopausal (history of ≥12 consecutive months without menses prior to randomization in the absence of other pathologic or physiologic causes and confirmed by follicle stimulating hormone \[fsh\] level ≥40 miu/ml) or b. women of childbearing potential who are not planning to be pregnant during the study period who meet all of criteria i-iii: i. negative serum pregnancy test at the screening visit. ii. negative urine pregnancy test on day 1 (a positive test will result in discontinuation from intervention). iii. using one of the following highly effective methods of contraception during the study: 1. combined estrogen and progestogen, or progestogen-only hormonal contraception associated with inhibition of ovulation (e.g., implants, pills, patches) initiated ≥30 days prior to study day 1. 2. intrauterine device (iud) or hormone releasing intrauterine system (ius) inserted ≥30 days prior to study day 1. 7. participant understands and agrees to comply with planned study procedures.

inclusion criteria: 1. able and willing to provide written informed consent (voluntarily signed by the participant) prior to performing study procedures. 2. females and males 18-59 years of age. 3. have a body mass index (bmi) less than or equal to 35.0 kg/m\^2 4. healthy, based on medical history (no chronic disease, no chronic therapy, no ongoing acute condition within four weeks prior to dosing), normal physical examination (no clinically significant findings in the opinion of the investigator), and screening laboratory assessments (no clinically significant findings in the opinion of the investigator). 5. no clinical symptoms suspicious for covid-19 infection, as well as sars-cov-2 immunoglobulin m (igm) antibody negative and no laboratory evidence of current sars-cov-2 infection (i.e., reverse transcription polymerase chain reaction (rt-pcr) negative for sars-cov-2) at screening. 6. females must not be pregnant, or trying to become pregnant as demonstrated by either of the following a or b: a. not of childbearing potential: surgically sterile (at least six weeks post bilateral salpingectomy, bilateral oophorectomy, or hysterectomy); or post-menopausal (history of ≥12 consecutive months without menses prior to randomization in the absence of other pathologic or physiologic causes and confirmed by follicle stimulating hormone \[fsh\] level ≥40 miu/ml) or b. women of childbearing potential who are not planning to be pregnant during the study period who meet all of criteria i-iii: i. negative serum pregnancy test at the screening visit. ii. negative urine pregnancy test on day 1 (a positive test will result in discontinuation from intervention). iii. using one of the following highly effective methods of contraception during the study: 1. combined estrogen and progestogen, or progestogen-only hormonal contraception associated with inhibition of ovulation (e.g., implants, pills, patches) initiated ≥30 days prior to study day 1. 2. intrauterine device (iud) or hormone releasing intrauterine system (ius) inserted ≥30 days prior to study day 1. 7. participant understands and agrees to comply with planned study procedures.

Dec. 18, 2021, 2:30 a.m. usa

inclusion criteria: able and willing to provide written informed consent (voluntarily signed by the participant) prior to performing study procedures. females and males 18-59 years of age. have a body mass index (bmi) less than or equal to 35.0 kg/m^2 healthy, based on medical history (no chronic disease, no chronic therapy, no ongoing acute condition within four weeks prior to dosing), normal physical examination (no clinically significant findings in the opinion of the investigator), and screening laboratory assessments (no clinically significant findings in the opinion of the investigator). no clinical symptoms suspicious for covid-19 infection, as well as sars-cov-2 immunoglobulin m (igm) antibody negative and no laboratory evidence of current sars-cov-2 infection (i.e., reverse transcription polymerase chain reaction (rt-pcr) negative for sars-cov-2) at screening. females must not be pregnant, or trying to become pregnant as demonstrated by either of the following a or b: a. not of childbearing potential: surgically sterile (at least six weeks post bilateral salpingectomy, bilateral oophorectomy, or hysterectomy); or post-menopausal (history of ≥12 consecutive months without menses prior to randomization in the absence of other pathologic or physiologic causes and confirmed by follicle stimulating hormone [fsh] level ≥40 miu/ml) or b. women of childbearing potential who are not planning to be pregnant during the study period who meet all of criteria i-iii: i. negative serum pregnancy test at the screening visit. ii. negative urine pregnancy test on day 1 (a positive test will result in discontinuation from intervention). iii. using one of the following highly effective methods of contraception during the study: combined estrogen and progestogen, or progestogen-only hormonal contraception associated with inhibition of ovulation (e.g., implants, pills, patches) initiated ≥30 days prior to study day 1. intrauterine device (iud) or hormone releasing intrauterine system (ius) inserted ≥30 days prior to study day 1. participant understands and agrees to comply with planned study procedures.

inclusion criteria: able and willing to provide written informed consent (voluntarily signed by the participant) prior to performing study procedures. females and males 18-59 years of age. have a body mass index (bmi) less than or equal to 35.0 kg/m^2 healthy, based on medical history (no chronic disease, no chronic therapy, no ongoing acute condition within four weeks prior to dosing), normal physical examination (no clinically significant findings in the opinion of the investigator), and screening laboratory assessments (no clinically significant findings in the opinion of the investigator). no clinical symptoms suspicious for covid-19 infection, as well as sars-cov-2 immunoglobulin m (igm) antibody negative and no laboratory evidence of current sars-cov-2 infection (i.e., reverse transcription polymerase chain reaction (rt-pcr) negative for sars-cov-2) at screening. females must not be pregnant, or trying to become pregnant as demonstrated by either of the following a or b: a. not of childbearing potential: surgically sterile (at least six weeks post bilateral salpingectomy, bilateral oophorectomy, or hysterectomy); or post-menopausal (history of ≥12 consecutive months without menses prior to randomization in the absence of other pathologic or physiologic causes and confirmed by follicle stimulating hormone [fsh] level ≥40 miu/ml) or b. women of childbearing potential who are not planning to be pregnant during the study period who meet all of criteria i-iii: i. negative serum pregnancy test at the screening visit. ii. negative urine pregnancy test on day 1 (a positive test will result in discontinuation from intervention). iii. using one of the following highly effective methods of contraception during the study: combined estrogen and progestogen, or progestogen-only hormonal contraception associated with inhibition of ovulation (e.g., implants, pills, patches) initiated ≥30 days prior to study day 1. intrauterine device (iud) or hormone releasing intrauterine system (ius) inserted ≥30 days prior to study day 1. participant understands and agrees to comply with planned study procedures.

Dec. 3, 2021, 11:30 p.m. usa

inclusion criteria: able and willing to provide written informed consent (voluntarily signed by the participant) prior to performing study procedures. females and males 18-59 years of age. have a body mass index (bmi) less than or equal to 35.0 kg/m^2 healthy, based on medical history (no chronic disease, no chronic therapy, no ongoing acute condition within four weeks prior to dosing), normal physical examination (no clinically significant findings in the opinion of the investigator), and screening laboratory assessments (no clinically significant findings in the opinion of the investigator). no clinical symptoms suspicious for covid-19 infection, as well as sars-cov-2 igm antibody negative and no laboratory evidence of current sars-cov-2 infection (i.e., rt-pcr negative for sars-cov-2) at screening. females must not be pregnant, or trying to become pregnant as demonstrated by either of the following a or b: a. not of childbearing potential: surgically sterile (at least six weeks post bilateral salpingectomy, bilateral oophorectomy, or hysterectomy); or post-menopausal (history of ≥12 consecutive months without menses prior to randomization in the absence of other pathologic or physiologic causes and confirmed by follicle stimulating hormone [fsh] level ≥40 miu/ml) or b. women of childbearing potential who are not planning to be pregnant during the study period who meet all of criteria i-iii: i. negative serum pregnancy test at the screening visit. ii. negative urine pregnancy test on day 1 (a positive test will result in discontinuation from intervention). iii. using one of the following highly effective methods of contraception during the study: combined estrogen and progestogen, or progestogen-only hormonal contraception associated with inhibition of ovulation (e.g., implants, pills, patches) initiated ≥30 days prior to study day 1. intrauterine device (iud) or hormone releasing intrauterine system (ius) inserted ≥30 days prior to study day 1. participant understands and agrees to comply with planned study procedures.

inclusion criteria: able and willing to provide written informed consent (voluntarily signed by the participant) prior to performing study procedures. females and males 18-59 years of age. have a body mass index (bmi) less than or equal to 35.0 kg/m^2 healthy, based on medical history (no chronic disease, no chronic therapy, no ongoing acute condition within four weeks prior to dosing), normal physical examination (no clinically significant findings in the opinion of the investigator), and screening laboratory assessments (no clinically significant findings in the opinion of the investigator). no clinical symptoms suspicious for covid-19 infection, as well as sars-cov-2 igm antibody negative and no laboratory evidence of current sars-cov-2 infection (i.e., rt-pcr negative for sars-cov-2) at screening. females must not be pregnant, or trying to become pregnant as demonstrated by either of the following a or b: a. not of childbearing potential: surgically sterile (at least six weeks post bilateral salpingectomy, bilateral oophorectomy, or hysterectomy); or post-menopausal (history of ≥12 consecutive months without menses prior to randomization in the absence of other pathologic or physiologic causes and confirmed by follicle stimulating hormone [fsh] level ≥40 miu/ml) or b. women of childbearing potential who are not planning to be pregnant during the study period who meet all of criteria i-iii: i. negative serum pregnancy test at the screening visit. ii. negative urine pregnancy test on day 1 (a positive test will result in discontinuation from intervention). iii. using one of the following highly effective methods of contraception during the study: combined estrogen and progestogen, or progestogen-only hormonal contraception associated with inhibition of ovulation (e.g., implants, pills, patches) initiated ≥30 days prior to study day 1. intrauterine device (iud) or hormone releasing intrauterine system (ius) inserted ≥30 days prior to study day 1. participant understands and agrees to comply with planned study procedures.