Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT05339334
Eligibility Criteria:
Inclusion Criteria:
* Healthy Chinese participants
* No clinical relevant abnormalities
* Body mass index (BMI):17.5-28
Exclusion Criteria:
* Any clinical significant illness
* History of alcohol abuse
* Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days prior the first study dose
* Abnormal clinical lab tests: aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin, estimated glomerular filtration rate (eGFR)
* Abnormal vital signs, such 12-electrocardiogram (ECG), blood pressure and pulse rate
* Blood donation within 60 days
* History of human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C antibody (HCVAb)
* Other medical or psychiatric may inappropriate for the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT05339334
Study Brief:
Protocol Section:
NCT05339334