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

inclusion criteria: * subject is a healthy male or female subject, aged between 18 to 60 years (both inclusive). health is defined as no clinically relevant abnormalities identified by investigator's decision based on a detailed medical history, full physical examination, including blood pressure, heart rate, respiratory rate, and body temperature measurement, electrocardiogram (ecg) and clinical laboratory tests prior to the study drug administration. * subject is confirmed as negative by sars-cov-2 rt-pcr testing on screening and prior to admission to the unit. * subject voluntarily agrees to participate in this study and has given written informed consent prior to undergoing any of the screening procedures. * willing and able to comply with all scheduled visits, treatment plan, clinical laboratory tests, lifestyle guidelines, methods of contraception, including covid-19 social distancing guidelines as described in section 5.7.2 (under "hygiene") from signing of informed consent through end of study on day 180. * female subjects of childbearing potential must not be planning a pregnancy or be pregnant or lactating. all female subjects must have a negative result for the pregnancy tests performed at screening and admission. * female subjects of childbearing potential (including perimenopausal females who have had a menstrual period within 1 year prior to screening) must agree to use a reliable method of contraception until study completion and for at least 4 weeks following their final study visit on day 180. reliable contraception is defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as hormonal contraception (oral, implant, injection, ring, or patch) and intrauterine contraceptive devices (iuds) at least 3 months prior to screening or a vasectomized partner. note: complete abstinence from sexual intercourse is acceptable. * female subject is of non-childbearing potential defined as surgically sterile (i.e. documented bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or at least 12 months postmenopausal (defined with no menses without an alternative medical cause and follicle stimulating hormone test in the post-menopausal range at the screening visit. * male subjects with partners of childbearing potential must have had surgical sterilization (vasectomy) at least 26 weeks prior to screening or use a male barrier method of contraception (i.e. male condom with spermicide) during any sexual intercourse, from study day -1 (beginning of confinement) until 3 months after the final follow-up visit on day 270. note: complete abstinence from sexual intercourse is acceptable. * male subjects must agree to abstain from sperm donation from initial study drug administration through 3 months after the last follow-up visit on day 180.

inclusion criteria: * subject is a healthy male or female subject, aged between 18 to 60 years (both inclusive). health is defined as no clinically relevant abnormalities identified by investigator's decision based on a detailed medical history, full physical examination, including blood pressure, heart rate, respiratory rate, and body temperature measurement, electrocardiogram (ecg) and clinical laboratory tests prior to the study drug administration. * subject is confirmed as negative by sars-cov-2 rt-pcr testing on screening and prior to admission to the unit. * subject voluntarily agrees to participate in this study and has given written informed consent prior to undergoing any of the screening procedures. * willing and able to comply with all scheduled visits, treatment plan, clinical laboratory tests, lifestyle guidelines, methods of contraception, including covid-19 social distancing guidelines as described in section 5.7.2 (under "hygiene") from signing of informed consent through end of study on day 180. * female subjects of childbearing potential must not be planning a pregnancy or be pregnant or lactating. all female subjects must have a negative result for the pregnancy tests performed at screening and admission. * female subjects of childbearing potential (including perimenopausal females who have had a menstrual period within 1 year prior to screening) must agree to use a reliable method of contraception until study completion and for at least 4 weeks following their final study visit on day 180. reliable contraception is defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as hormonal contraception (oral, implant, injection, ring, or patch) and intrauterine contraceptive devices (iuds) at least 3 months prior to screening or a vasectomized partner. note: complete abstinence from sexual intercourse is acceptable. * female subject is of non-childbearing potential defined as surgically sterile (i.e. documented bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or at least 12 months postmenopausal (defined with no menses without an alternative medical cause and follicle stimulating hormone test in the post-menopausal range at the screening visit. * male subjects with partners of childbearing potential must have had surgical sterilization (vasectomy) at least 26 weeks prior to screening or use a male barrier method of contraception (i.e. male condom with spermicide) during any sexual intercourse, from study day -1 (beginning of confinement) until 3 months after the final follow-up visit on day 270. note: complete abstinence from sexual intercourse is acceptable. * male subjects must agree to abstain from sperm donation from initial study drug administration through 3 months after the last follow-up visit on day 180.

Dec. 30, 2020, 12:31 a.m. usa

inclusion criteria: - subject is a healthy male or female subject, aged between 18 to 60 years (both inclusive). health is defined as no clinically relevant abnormalities identified by investigator's decision based on a detailed medical history, full physical examination, including blood pressure, heart rate, respiratory rate, and body temperature measurement, electrocardiogram (ecg) and clinical laboratory tests prior to the study drug administration. - subject is confirmed as negative by sars-cov-2 rt-pcr testing on screening and prior to admission to the unit. - subject voluntarily agrees to participate in this study and has given written informed consent prior to undergoing any of the screening procedures. - willing and able to comply with all scheduled visits, treatment plan, clinical laboratory tests, lifestyle guidelines, methods of contraception, including covid-19 social distancing guidelines as described in section 5.7.2 (under "hygiene") from signing of informed consent through end of study on day 180. - female subjects of childbearing potential must not be planning a pregnancy or be pregnant or lactating. all female subjects must have a negative result for the pregnancy tests performed at screening and admission. - female subjects of childbearing potential (including perimenopausal females who have had a menstrual period within 1 year prior to screening) must agree to use a reliable method of contraception until study completion and for at least 4 weeks following their final study visit on day 180. reliable contraception is defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as hormonal contraception (oral, implant, injection, ring, or patch) and intrauterine contraceptive devices (iuds) at least 3 months prior to screening or a vasectomized partner. note: complete abstinence from sexual intercourse is acceptable. - female subject is of non-childbearing potential defined as surgically sterile (i.e. documented bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or at least 12 months postmenopausal (defined with no menses without an alternative medical cause and follicle stimulating hormone test in the post-menopausal range at the screening visit. - male subjects with partners of childbearing potential must have had surgical sterilization (vasectomy) at least 26 weeks prior to screening or use a male barrier method of contraception (i.e. male condom with spermicide) during any sexual intercourse, from study day -1 (beginning of confinement) until 3 months after the final follow-up visit on day 270. note: complete abstinence from sexual intercourse is acceptable. - male subjects must agree to abstain from sperm donation from initial study drug administration through 3 months after the last follow-up visit on day 180.

inclusion criteria: - subject is a healthy male or female subject, aged between 18 to 60 years (both inclusive). health is defined as no clinically relevant abnormalities identified by investigator's decision based on a detailed medical history, full physical examination, including blood pressure, heart rate, respiratory rate, and body temperature measurement, electrocardiogram (ecg) and clinical laboratory tests prior to the study drug administration. - subject is confirmed as negative by sars-cov-2 rt-pcr testing on screening and prior to admission to the unit. - subject voluntarily agrees to participate in this study and has given written informed consent prior to undergoing any of the screening procedures. - willing and able to comply with all scheduled visits, treatment plan, clinical laboratory tests, lifestyle guidelines, methods of contraception, including covid-19 social distancing guidelines as described in section 5.7.2 (under "hygiene") from signing of informed consent through end of study on day 180. - female subjects of childbearing potential must not be planning a pregnancy or be pregnant or lactating. all female subjects must have a negative result for the pregnancy tests performed at screening and admission. - female subjects of childbearing potential (including perimenopausal females who have had a menstrual period within 1 year prior to screening) must agree to use a reliable method of contraception until study completion and for at least 4 weeks following their final study visit on day 180. reliable contraception is defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as hormonal contraception (oral, implant, injection, ring, or patch) and intrauterine contraceptive devices (iuds) at least 3 months prior to screening or a vasectomized partner. note: complete abstinence from sexual intercourse is acceptable. - female subject is of non-childbearing potential defined as surgically sterile (i.e. documented bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or at least 12 months postmenopausal (defined with no menses without an alternative medical cause and follicle stimulating hormone test in the post-menopausal range at the screening visit. - male subjects with partners of childbearing potential must have had surgical sterilization (vasectomy) at least 26 weeks prior to screening or use a male barrier method of contraception (i.e. male condom with spermicide) during any sexual intercourse, from study day -1 (beginning of confinement) until 3 months after the final follow-up visit on day 270. note: complete abstinence from sexual intercourse is acceptable. - male subjects must agree to abstain from sperm donation from initial study drug administration through 3 months after the last follow-up visit on day 180.

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

inclusion criteria: - subject is a healthy male or female subject, aged between 18 to 60 years (both inclusive). health is defined as no clinically relevant abnormalities identified by investigator's decision based on a detailed medical history, full physical examination, including blood pressure, heart rate, respiratory rate, and body temperature measurement, electrocardiogram (ecg) and clinical laboratory tests prior to the study drug administration. - subject is confirmed as negative by sars-cov-2 rt-pcr testing on screening and prior to admission to the unit. - subject voluntarily agrees to participate in this study and has given written informed consent prior to undergoing any of the screening procedures. - willing and able to comply with all scheduled visits, treatment plan, clinical laboratory tests, lifestyle guidelines, methods of contraception, including covid-19 social distancing guidelines as described in section 5.7.2 (under "hygiene") from signing of informed consent through end of study on day 270. - subject with a body weight of ≥ 50 kg and a body mass index between 18 and 33 kg/m2 inclusive. - female subjects of childbearing potential must not be planning a pregnancy or be pregnant or lactating. all female subjects must have a negative result for the pregnancy tests performed at screening and admission. - female subjects of childbearing potential (including perimenopausal females who have had a menstrual period within 1 year prior to screening) must agree to use a reliable method of contraception until study completion and for at least 3 weeks following their final study visit on day 270. reliable contraception is defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as hormonal contraception (oral, implant, injection, ring, or patch) and intrauterine contraceptive devices (iuds) at least 3 months prior to screening or a vasectomized partner. note: complete abstinence from sexual intercourse is acceptable. - female subject is of non-childbearing potential defined as surgically sterile (i.e. documented bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or at least 12 months postmenopausal (defined with no menses without an alternative medical cause and follicle stimulating hormone test in the post-menopausal range at the screening visit. - male subjects with partners of childbearing potential must have had surgical sterilization (vasectomy) at least 26 weeks prior to screening or use a male barrier method of contraception (i.e. male condom with spermicide) during any sexual intercourse, from study day -1 (beginning of confinement) until 3 months after the final follow-up visit on day 270. note: complete abstinence from sexual intercourse is acceptable. - male subjects must agree to abstain from sperm donation from initial study drug administration through 3 months after the last follow-up visit on day 270.

inclusion criteria: - subject is a healthy male or female subject, aged between 18 to 60 years (both inclusive). health is defined as no clinically relevant abnormalities identified by investigator's decision based on a detailed medical history, full physical examination, including blood pressure, heart rate, respiratory rate, and body temperature measurement, electrocardiogram (ecg) and clinical laboratory tests prior to the study drug administration. - subject is confirmed as negative by sars-cov-2 rt-pcr testing on screening and prior to admission to the unit. - subject voluntarily agrees to participate in this study and has given written informed consent prior to undergoing any of the screening procedures. - willing and able to comply with all scheduled visits, treatment plan, clinical laboratory tests, lifestyle guidelines, methods of contraception, including covid-19 social distancing guidelines as described in section 5.7.2 (under "hygiene") from signing of informed consent through end of study on day 270. - subject with a body weight of ≥ 50 kg and a body mass index between 18 and 33 kg/m2 inclusive. - female subjects of childbearing potential must not be planning a pregnancy or be pregnant or lactating. all female subjects must have a negative result for the pregnancy tests performed at screening and admission. - female subjects of childbearing potential (including perimenopausal females who have had a menstrual period within 1 year prior to screening) must agree to use a reliable method of contraception until study completion and for at least 3 weeks following their final study visit on day 270. reliable contraception is defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as hormonal contraception (oral, implant, injection, ring, or patch) and intrauterine contraceptive devices (iuds) at least 3 months prior to screening or a vasectomized partner. note: complete abstinence from sexual intercourse is acceptable. - female subject is of non-childbearing potential defined as surgically sterile (i.e. documented bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or at least 12 months postmenopausal (defined with no menses without an alternative medical cause and follicle stimulating hormone test in the post-menopausal range at the screening visit. - male subjects with partners of childbearing potential must have had surgical sterilization (vasectomy) at least 26 weeks prior to screening or use a male barrier method of contraception (i.e. male condom with spermicide) during any sexual intercourse, from study day -1 (beginning of confinement) until 3 months after the final follow-up visit on day 270. note: complete abstinence from sexual intercourse is acceptable. - male subjects must agree to abstain from sperm donation from initial study drug administration through 3 months after the last follow-up visit on day 270.