Created at Source Raw Value Validated value
Nov. 16, 2021, 6:30 p.m. usa

inclusion criteria: informed consent understood and signed healthy male or healthy, non-pregnant, non-lactating female willingness to comply and be available for all protocol procedures for the duration of the study between the ages of 18 and 55, inclusive on the day of dosing body mass index (bmi) of ≥18.5 and ≤35 kg/m2 female subjects of childbearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test on day 1 prior to dosing. note: a woman is considered of childbearing potential unless post-menopausal (> or = 1 year without menses without other known or suspected cause and appropriately elevated fsh) or surgically sterilized via bilateral oophorectomy or hysterectomy females of childbearing potential and males agree to use acceptable contraception for the duration of the study note: these include progestin implants, intrauterine devices (iuds), surgical (hysterectomy or tubal ligation; vasectomy) or abstinence. use of methods such as progestin injectables, combined oral hormonal contraceptives, condoms, and diaphragms will not be acceptable when used alone, but they could be considered, if used in combination with another method (for example, a female using combined oral contraceptives if her male partner is sterile, or if she and her non-sterile male partner use a double-barrier method), after consultation with the ology bioservices mm. all males will be required to use a barrier method (condoms) for the duration of the study screening laboratory tests are within normal ranges or outside the normal ranges and considered not clinically significant by the principal investigator if urinalysis by dipstick is abnormal, a complete urinalysis with microscopic evaluation will be performed and the results will supersede the results of the dipstick for blood, glucose, and protein. menstruating females failing inclusion criteria due to a positive blood on urine test may be retested following cessation of menses. other laboratory values that are outside the range of eligibility but are thought to be due to an acute condition or collection or laboratory error may be repeated once. the urine drug screen is negative breathalyzer test or blood/saliva alcohol test is negative and subject agrees to abstain from alcohol consumption for a period of 2 days prior to dosing and 2 days prior to any study visit. agree to minimize risk of sars-cov-2 infection.

inclusion criteria: informed consent understood and signed healthy male or healthy, non-pregnant, non-lactating female willingness to comply and be available for all protocol procedures for the duration of the study between the ages of 18 and 55, inclusive on the day of dosing body mass index (bmi) of ≥18.5 and ≤35 kg/m2 female subjects of childbearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test on day 1 prior to dosing. note: a woman is considered of childbearing potential unless post-menopausal (> or = 1 year without menses without other known or suspected cause and appropriately elevated fsh) or surgically sterilized via bilateral oophorectomy or hysterectomy females of childbearing potential and males agree to use acceptable contraception for the duration of the study note: these include progestin implants, intrauterine devices (iuds), surgical (hysterectomy or tubal ligation; vasectomy) or abstinence. use of methods such as progestin injectables, combined oral hormonal contraceptives, condoms, and diaphragms will not be acceptable when used alone, but they could be considered, if used in combination with another method (for example, a female using combined oral contraceptives if her male partner is sterile, or if she and her non-sterile male partner use a double-barrier method), after consultation with the ology bioservices mm. all males will be required to use a barrier method (condoms) for the duration of the study screening laboratory tests are within normal ranges or outside the normal ranges and considered not clinically significant by the principal investigator if urinalysis by dipstick is abnormal, a complete urinalysis with microscopic evaluation will be performed and the results will supersede the results of the dipstick for blood, glucose, and protein. menstruating females failing inclusion criteria due to a positive blood on urine test may be retested following cessation of menses. other laboratory values that are outside the range of eligibility but are thought to be due to an acute condition or collection or laboratory error may be repeated once. the urine drug screen is negative breathalyzer test or blood/saliva alcohol test is negative and subject agrees to abstain from alcohol consumption for a period of 2 days prior to dosing and 2 days prior to any study visit. agree to minimize risk of sars-cov-2 infection.

Sept. 27, 2021, 7:30 a.m. usa

inclusion criteria: 1. informed consent understood and signed 2. healthy male or healthy, non-pregnant, non-lactating female 3. willingness to comply and be available for all protocol procedures for the duration of the study 4. between the ages of 18 and 55, inclusive on the day of dosing 5. body mass index (bmi) of ≥18.5 and ≤35 kg/m2 6. female subjects of childbearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test on day 1 prior to dosing. - note: a woman is considered of childbearing potential unless post-menopausal (> or = 1 year without menses without other known or suspected cause and appropriately elevated fsh) or surgically sterilized via bilateral oophorectomy or hysterectomy 7. females of childbearing potential and males agree to use acceptable contraception for the duration of the study - note: these include progestin implants, intrauterine devices (iuds), surgical (hysterectomy or tubal ligation; vasectomy) or abstinence. use of methods such as progestin injectables, combined oral hormonal contraceptives, condoms, and diaphragms will not be acceptable when used alone, but they could be considered, if used in combination with another method (for example, a female using combined oral contraceptives if her male partner is sterile, or if she and her non-sterile male partner use a double-barrier method), after consultation with the ology bioservices mm. all males will be required to use a barrier method (condoms) for the duration of the study 8. screening laboratory tests are within normal ranges or outside the normal ranges and considered not clinically significant by the principal investigator 1. if urinalysis by dipstick is abnormal, a complete urinalysis with microscopic evaluation will be performed and the results will supersede the results of the dipstick for blood, glucose, and protein. 2. menstruating females failing inclusion criteria due to a positive blood on urine test may be retested following cessation of menses. 3. other laboratory values that are outside the range of eligibility but are thought to be due to an acute condition or collection or laboratory error may be repeated once. 9. the urine drug screen is negative 10. breathalyzer test or blood/saliva alcohol test is negative and subject agrees to abstain from alcohol consumption for a period of 2 days prior to dosing and 2 days prior to any study visit. 11. agree to minimize risk of sars-cov-2 infection.

inclusion criteria: 1. informed consent understood and signed 2. healthy male or healthy, non-pregnant, non-lactating female 3. willingness to comply and be available for all protocol procedures for the duration of the study 4. between the ages of 18 and 55, inclusive on the day of dosing 5. body mass index (bmi) of ≥18.5 and ≤35 kg/m2 6. female subjects of childbearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test on day 1 prior to dosing. - note: a woman is considered of childbearing potential unless post-menopausal (> or = 1 year without menses without other known or suspected cause and appropriately elevated fsh) or surgically sterilized via bilateral oophorectomy or hysterectomy 7. females of childbearing potential and males agree to use acceptable contraception for the duration of the study - note: these include progestin implants, intrauterine devices (iuds), surgical (hysterectomy or tubal ligation; vasectomy) or abstinence. use of methods such as progestin injectables, combined oral hormonal contraceptives, condoms, and diaphragms will not be acceptable when used alone, but they could be considered, if used in combination with another method (for example, a female using combined oral contraceptives if her male partner is sterile, or if she and her non-sterile male partner use a double-barrier method), after consultation with the ology bioservices mm. all males will be required to use a barrier method (condoms) for the duration of the study 8. screening laboratory tests are within normal ranges or outside the normal ranges and considered not clinically significant by the principal investigator 1. if urinalysis by dipstick is abnormal, a complete urinalysis with microscopic evaluation will be performed and the results will supersede the results of the dipstick for blood, glucose, and protein. 2. menstruating females failing inclusion criteria due to a positive blood on urine test may be retested following cessation of menses. 3. other laboratory values that are outside the range of eligibility but are thought to be due to an acute condition or collection or laboratory error may be repeated once. 9. the urine drug screen is negative 10. breathalyzer test or blood/saliva alcohol test is negative and subject agrees to abstain from alcohol consumption for a period of 2 days prior to dosing and 2 days prior to any study visit. 11. agree to minimize risk of sars-cov-2 infection.

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

inclusion criteria: 1. informed consent understood and signed 2. healthy male or healthy, non-pregnant, non-lactating female 3. willingness to comply and be available for all protocol procedures for the duration of the study 4. between the ages of 18 and 55, inclusive on the day of dosing 5. body mass index (bmi) of ≥18.5 and ≤35 kg/m2 6. female subjects of childbearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test on day 1 prior to dosing. - note: a woman is considered of childbearing potential unless post-menopausal (> or = 1 year without menses without other known or suspected cause and appropriately elevated fsh) or surgically sterilized via bilateral oophorectomy or hysterectomy 7. females of childbearing potential and males agree to use acceptable contraception for the duration of the study - note: these include progestin implants, intrauterine devices (iuds), surgical (hysterectomy or tubal ligation; vasectomy) or abstinence. use of methods such as progestin injectables, combined oral hormonal contraceptives, condoms, and diaphragms will not be acceptable when used alone, but they could be considered, if used in combination with another method (for example, a female using combined oral contraceptives if her male partner is sterile, or if she and her non-sterile male partner use a double-barrier method), after consultation with the ology bioservices mm. all males will be required to use a barrier method (condoms) for the duration of the study 8. screening laboratory tests are within normal ranges or outside the normal ranges and considered not clinically significant by the principal investigator 1. if urinalysis by dipstick is abnormal, a complete urinalysis with microscopic evaluation will be performed and the results will supersede the results of the dipstick for blood, glucose, and protein. 2. menstruating females failing inclusion criteria due to a positive blood on urine test may be retested following cessation of menses. 3. other laboratory values that are outside the range of eligibility but are thought to be due to an acute condition or collection or laboratory error may be repeated once. 9. the urine drug screen is negative 10. breathalyzer test is negative and subject agrees to abstain from alcohol consumption for a period of 2 days prior to dosing and 2 days prior to any study visit. 11. agree to minimize risk of sars-cov-2 infection.

inclusion criteria: 1. informed consent understood and signed 2. healthy male or healthy, non-pregnant, non-lactating female 3. willingness to comply and be available for all protocol procedures for the duration of the study 4. between the ages of 18 and 55, inclusive on the day of dosing 5. body mass index (bmi) of ≥18.5 and ≤35 kg/m2 6. female subjects of childbearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test on day 1 prior to dosing. - note: a woman is considered of childbearing potential unless post-menopausal (> or = 1 year without menses without other known or suspected cause and appropriately elevated fsh) or surgically sterilized via bilateral oophorectomy or hysterectomy 7. females of childbearing potential and males agree to use acceptable contraception for the duration of the study - note: these include progestin implants, intrauterine devices (iuds), surgical (hysterectomy or tubal ligation; vasectomy) or abstinence. use of methods such as progestin injectables, combined oral hormonal contraceptives, condoms, and diaphragms will not be acceptable when used alone, but they could be considered, if used in combination with another method (for example, a female using combined oral contraceptives if her male partner is sterile, or if she and her non-sterile male partner use a double-barrier method), after consultation with the ology bioservices mm. all males will be required to use a barrier method (condoms) for the duration of the study 8. screening laboratory tests are within normal ranges or outside the normal ranges and considered not clinically significant by the principal investigator 1. if urinalysis by dipstick is abnormal, a complete urinalysis with microscopic evaluation will be performed and the results will supersede the results of the dipstick for blood, glucose, and protein. 2. menstruating females failing inclusion criteria due to a positive blood on urine test may be retested following cessation of menses. 3. other laboratory values that are outside the range of eligibility but are thought to be due to an acute condition or collection or laboratory error may be repeated once. 9. the urine drug screen is negative 10. breathalyzer test is negative and subject agrees to abstain from alcohol consumption for a period of 2 days prior to dosing and 2 days prior to any study visit. 11. agree to minimize risk of sars-cov-2 infection.