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

inclusion criteria: 1. adult ≥ 18 years old inclusive at the time of randomization. 2. having no clinically significant acute medical condition, and no chronic medical condition that has not been controlled within 90 days of randomization, as determined by medical history, physical examination, screening laboratory test results, and clinical assessment of the investigator. 3. has provided written informed consent prior to performance of any study-specific procedure. 4. has a body mass index (bmi) of 17 to 40 kg/m2, inclusive, at screening. 5. resides in study site area and is able and willing to adhere to all protocol visits and procedures. 6. if a woman is of childbearing potential age, must not be breastfeeding or be pregnant (based on a negative urine pregnancy test at screening and during the 24 hours prior to receipt of the first dose of ip), must plan to avoid pregnancy for at least 28 days after the last dose of ip, and be willing to use an adequate method of contraception consistently and have a repeated pregnancy test prior to the second (last) dose of ip.

inclusion criteria: 1. adult ≥ 18 years old inclusive at the time of randomization. 2. having no clinically significant acute medical condition, and no chronic medical condition that has not been controlled within 90 days of randomization, as determined by medical history, physical examination, screening laboratory test results, and clinical assessment of the investigator. 3. has provided written informed consent prior to performance of any study-specific procedure. 4. has a body mass index (bmi) of 17 to 40 kg/m2, inclusive, at screening. 5. resides in study site area and is able and willing to adhere to all protocol visits and procedures. 6. if a woman is of childbearing potential age, must not be breastfeeding or be pregnant (based on a negative urine pregnancy test at screening and during the 24 hours prior to receipt of the first dose of ip), must plan to avoid pregnancy for at least 28 days after the last dose of ip, and be willing to use an adequate method of contraception consistently and have a repeated pregnancy test prior to the second (last) dose of ip.

July 12, 2023, 8 p.m. usa

inclusion criteria: adult ≥ 18 years old inclusive at the time of randomization. having no clinically significant acute medical condition, and no chronic medical condition that has not been controlled within 90 days of randomization, as determined by medical history, physical examination, screening laboratory test results, and clinical assessment of the investigator. has provided written informed consent prior to performance of any study-specific procedure. has a body mass index (bmi) of 17 to 40 kg/m2, inclusive, at screening. resides in study site area and is able and willing to adhere to all protocol visits and procedures. if a woman is of childbearing potential age, must not be breastfeeding or be pregnant (based on a negative urine pregnancy test at screening and during the 24 hours prior to receipt of the first dose of ip), must plan to avoid pregnancy for at least 28 days after the last dose of ip, and be willing to use an adequate method of contraception consistently and have a repeated pregnancy test prior to the second (last) dose of ip.

inclusion criteria: adult ≥ 18 years old inclusive at the time of randomization. having no clinically significant acute medical condition, and no chronic medical condition that has not been controlled within 90 days of randomization, as determined by medical history, physical examination, screening laboratory test results, and clinical assessment of the investigator. has provided written informed consent prior to performance of any study-specific procedure. has a body mass index (bmi) of 17 to 40 kg/m2, inclusive, at screening. resides in study site area and is able and willing to adhere to all protocol visits and procedures. if a woman is of childbearing potential age, must not be breastfeeding or be pregnant (based on a negative urine pregnancy test at screening and during the 24 hours prior to receipt of the first dose of ip), must plan to avoid pregnancy for at least 28 days after the last dose of ip, and be willing to use an adequate method of contraception consistently and have a repeated pregnancy test prior to the second (last) dose of ip.