Created at Source Raw Value Validated value
July 23, 2021, 10:30 p.m. usa

inclusion criteria: a signed informed consent form (icf) from the patient or their legally authorized representative. healthy males or females, ages ≥18 to ≤45 years. male subjects with weight ≥50 kg, or female subjects with weight ≥45 kg, and body mass index (bmi) 19.0≤bmi≤26.0 kg/m2. no abnormality, or no clinically significant abnormality in vital signs, physical examination, laboratory tests, and 12-lead ecg in chinese healthy subjects during the screening period. female patients of childbearing potential (defined as female subjects who do not receive any operative sterilization or who had been through menopause for less than 1 year) must have a negative result for pregnancy test at screening. male and female subjects with childbearing potential must agree to adopt effective contraceptive methods at least from 2 weeks prior to screening to 6 months after administration of the investigational drug.

inclusion criteria: a signed informed consent form (icf) from the patient or their legally authorized representative. healthy males or females, ages ≥18 to ≤45 years. male subjects with weight ≥50 kg, or female subjects with weight ≥45 kg, and body mass index (bmi) 19.0≤bmi≤26.0 kg/m2. no abnormality, or no clinically significant abnormality in vital signs, physical examination, laboratory tests, and 12-lead ecg in chinese healthy subjects during the screening period. female patients of childbearing potential (defined as female subjects who do not receive any operative sterilization or who had been through menopause for less than 1 year) must have a negative result for pregnancy test at screening. male and female subjects with childbearing potential must agree to adopt effective contraceptive methods at least from 2 weeks prior to screening to 6 months after administration of the investigational drug.