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

inclusion criteria: * able to communicate with investigator, and to provide informed consent and have signed informed consent form (icf) prior to screening procedures * adults aged 19 to 50 years (for part a) or aged 19 to 64 (for part b) * judged to be healthy by the investigator on the basis of medical history, physical examination and vital signs performed at screening * able and willing to comply with all study procedures * screening laboratory results within normal limits for testing laboratory or deemed not clinically significant by the investigator * negative serological tests for hepatitis b surface antigen (hbsag), hepatitis c antibody and human immunodeficiency virus (hiv) antibody or rapid test at screening * screening ecg and chest x-ray deemed by the investigator as having no clinically significant findings (e.g. wolff-parkinson-white syndrome); * must meet one of the following criteria with respect to reproductive capacity: a. women who are post-menopausal as defined by spontaneous amenorrhea for ≥ 12 months b. surgically sterile or have a partner who is sterile (i.e., vasectomy in males or tubal ligation, absence of ovaries and/or uterus in females). in the case of vasectomy, subjects should wait six (6) months post-vasectomy prior to enrolling c. use of medically effective contraception with a failure rate of \< 1% per year when used consistently and correctly from screening until 3 months following last dose. acceptable methods include (but not limited to): c-1. hormonal contraception including implants, injections or oral c-2. two barrier methods, e.g., condom and cervical cap (with spermicide) or diaphragm (with spermicide)

inclusion criteria: * able to communicate with investigator, and to provide informed consent and have signed informed consent form (icf) prior to screening procedures * adults aged 19 to 50 years (for part a) or aged 19 to 64 (for part b) * judged to be healthy by the investigator on the basis of medical history, physical examination and vital signs performed at screening * able and willing to comply with all study procedures * screening laboratory results within normal limits for testing laboratory or deemed not clinically significant by the investigator * negative serological tests for hepatitis b surface antigen (hbsag), hepatitis c antibody and human immunodeficiency virus (hiv) antibody or rapid test at screening * screening ecg and chest x-ray deemed by the investigator as having no clinically significant findings (e.g. wolff-parkinson-white syndrome); * must meet one of the following criteria with respect to reproductive capacity: a. women who are post-menopausal as defined by spontaneous amenorrhea for ≥ 12 months b. surgically sterile or have a partner who is sterile (i.e., vasectomy in males or tubal ligation, absence of ovaries and/or uterus in females). in the case of vasectomy, subjects should wait six (6) months post-vasectomy prior to enrolling c. use of medically effective contraception with a failure rate of \< 1% per year when used consistently and correctly from screening until 3 months following last dose. acceptable methods include (but not limited to): c-1. hormonal contraception including implants, injections or oral c-2. two barrier methods, e.g., condom and cervical cap (with spermicide) or diaphragm (with spermicide)

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

inclusion criteria: - able to communicate with investigator, and to provide informed consent and have signed informed consent form (icf) prior to screening procedures - adults aged 19 to 50 years (for part a) or aged 19 to 64 (for part b) - judged to be healthy by the investigator on the basis of medical history, physical examination and vital signs performed at screening - able and willing to comply with all study procedures - screening laboratory results within normal limits for testing laboratory or deemed not clinically significant by the investigator - negative serological tests for hepatitis b surface antigen (hbsag), hepatitis c antibody and human immunodeficiency virus (hiv) antibody or rapid test at screening - screening ecg and chest x-ray deemed by the investigator as having no clinically significant findings (e.g. wolff-parkinson-white syndrome); - must meet one of the following criteria with respect to reproductive capacity: a. women who are post-menopausal as defined by spontaneous amenorrhea for ≥ 12 months b. surgically sterile or have a partner who is sterile (i.e., vasectomy in males or tubal ligation, absence of ovaries and/or uterus in females). in the case of vasectomy, subjects should wait six (6) months post-vasectomy prior to enrolling c. use of medically effective contraception with a failure rate of < 1% per year when used consistently and correctly from screening until 3 months following last dose. acceptable methods include (but not limited to): c-1. hormonal contraception including implants, injections or oral c-2. two barrier methods, e.g., condom and cervical cap (with spermicide) or diaphragm (with spermicide)

inclusion criteria: - able to communicate with investigator, and to provide informed consent and have signed informed consent form (icf) prior to screening procedures - adults aged 19 to 50 years (for part a) or aged 19 to 64 (for part b) - judged to be healthy by the investigator on the basis of medical history, physical examination and vital signs performed at screening - able and willing to comply with all study procedures - screening laboratory results within normal limits for testing laboratory or deemed not clinically significant by the investigator - negative serological tests for hepatitis b surface antigen (hbsag), hepatitis c antibody and human immunodeficiency virus (hiv) antibody or rapid test at screening - screening ecg and chest x-ray deemed by the investigator as having no clinically significant findings (e.g. wolff-parkinson-white syndrome); - must meet one of the following criteria with respect to reproductive capacity: a. women who are post-menopausal as defined by spontaneous amenorrhea for ≥ 12 months b. surgically sterile or have a partner who is sterile (i.e., vasectomy in males or tubal ligation, absence of ovaries and/or uterus in females). in the case of vasectomy, subjects should wait six (6) months post-vasectomy prior to enrolling c. use of medically effective contraception with a failure rate of < 1% per year when used consistently and correctly from screening until 3 months following last dose. acceptable methods include (but not limited to): c-1. hormonal contraception including implants, injections or oral c-2. two barrier methods, e.g., condom and cervical cap (with spermicide) or diaphragm (with spermicide)