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

inclusion criteria: phase 1 only: 1. adult 18 through 59 years of age, inclusive, at screening 2. healthy, as defined by absence of clinically significant medical condition, either acute or chronic, as determined by medical history, physical examination, screening laboratory test results, and clinical assessment of the investigator. phase 2 only: 1. adult 18 through 75 years of age, inclusive, at screening. 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. both phase 1 and phase 2: 1. has provided written informed consent prior to performance of any study-specific procedure. 2. has a body mass index (bmi) of 17 to 40 kg/m2, inclusive, at screening. 3. resides in study site area and is able and willing to adhere to all protocol visits and procedures. 4. if a woman is of childbearing potential, must not be breastfeeding or be pregnant (based on a negative serum pregnancy test at screening and a negative urine pregnancy test 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: phase 1 only: 1. adult 18 through 59 years of age, inclusive, at screening 2. healthy, as defined by absence of clinically significant medical condition, either acute or chronic, as determined by medical history, physical examination, screening laboratory test results, and clinical assessment of the investigator. phase 2 only: 1. adult 18 through 75 years of age, inclusive, at screening. 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. both phase 1 and phase 2: 1. has provided written informed consent prior to performance of any study-specific procedure. 2. has a body mass index (bmi) of 17 to 40 kg/m2, inclusive, at screening. 3. resides in study site area and is able and willing to adhere to all protocol visits and procedures. 4. if a woman is of childbearing potential, must not be breastfeeding or be pregnant (based on a negative serum pregnancy test at screening and a negative urine pregnancy test 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.

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

inclusion criteria: phase 1 only: adult 18 through 59 years of age, inclusive, at screening healthy, as defined by absence of clinically significant medical condition, either acute or chronic, as determined by medical history, physical examination, screening laboratory test results, and clinical assessment of the investigator. phase 2 only: adult 18 through 75 years of age, inclusive, at screening. 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. both phase 1 and phase 2: 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, must not be breastfeeding or be pregnant (based on a negative serum pregnancy test at screening and a negative urine pregnancy test 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: phase 1 only: adult 18 through 59 years of age, inclusive, at screening healthy, as defined by absence of clinically significant medical condition, either acute or chronic, as determined by medical history, physical examination, screening laboratory test results, and clinical assessment of the investigator. phase 2 only: adult 18 through 75 years of age, inclusive, at screening. 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. both phase 1 and phase 2: 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, must not be breastfeeding or be pregnant (based on a negative serum pregnancy test at screening and a negative urine pregnancy test 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.

April 6, 2021, 12:31 a.m. usa

inclusion criteria: phase 1 only: 1. adult 18 through 59 years of age, inclusive, at screening 2. healthy, as defined by absence of clinically significant medical condition, either acute or chronic, as determined by medical history, physical examination, screening laboratory test results, and clinical assessment of the investigator. phase 2 only: 1. adult 18 through 75 years of age, inclusive, at screening. 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. both phase 1 and phase 2: 1. has provided written informed consent prior to performance of any study-specific procedure. 2. has a body mass index (bmi) of 17 to 40 kg/m2, inclusive, at screening. 3. resides in study site area and is able and willing to adhere to all protocol visits and procedures. 4. if a woman is of childbearing potential, must not be breastfeeding or be pregnant (based on a negative serum pregnancy test at screening and a negative urine pregnancy test 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: phase 1 only: 1. adult 18 through 59 years of age, inclusive, at screening 2. healthy, as defined by absence of clinically significant medical condition, either acute or chronic, as determined by medical history, physical examination, screening laboratory test results, and clinical assessment of the investigator. phase 2 only: 1. adult 18 through 75 years of age, inclusive, at screening. 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. both phase 1 and phase 2: 1. has provided written informed consent prior to performance of any study-specific procedure. 2. has a body mass index (bmi) of 17 to 40 kg/m2, inclusive, at screening. 3. resides in study site area and is able and willing to adhere to all protocol visits and procedures. 4. if a woman is of childbearing potential, must not be breastfeeding or be pregnant (based on a negative serum pregnancy test at screening and a negative urine pregnancy test 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.

Feb. 23, 2021, 12:31 a.m. usa

inclusion criteria: phase 1 only: 1. adult 18 through 59 years of age inclusive at the time of randomization 2. healthy, as defined by absence of clinically significant medical condition, either acute or chronic, as determined by medical history, physical examination, screening laboratory test results, and clinical assessment of the investigator. phase 2 only: 1. adult 18 through 75 years of age 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. both phase 1 and phase 2: 1. has provided written informed consent prior to performance of any study-specific procedure. 2. has a body mass index (bmi) of 17 to 40 kg/m2, inclusive, at screening. 3. resides in study site area and is able and willing to adhere to all protocol visits and procedures. 4. if a woman is of childbearing potential, must not be breastfeeding or be pregnant (based on a negative serum pregnancy test at screening and a negative urine pregnancy test 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: phase 1 only: 1. adult 18 through 59 years of age inclusive at the time of randomization 2. healthy, as defined by absence of clinically significant medical condition, either acute or chronic, as determined by medical history, physical examination, screening laboratory test results, and clinical assessment of the investigator. phase 2 only: 1. adult 18 through 75 years of age 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. both phase 1 and phase 2: 1. has provided written informed consent prior to performance of any study-specific procedure. 2. has a body mass index (bmi) of 17 to 40 kg/m2, inclusive, at screening. 3. resides in study site area and is able and willing to adhere to all protocol visits and procedures. 4. if a woman is of childbearing potential, must not be breastfeeding or be pregnant (based on a negative serum pregnancy test at screening and a negative urine pregnancy test 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.