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:
2025-12-24 @ 5:26 PM
Ignite Modification Date:
2025-12-24 @ 5:26 PM
NCT ID:
NCT04126668
Eligibility Criteria:
Inclusion Criteria:
* age: 18 - 45 years;
* sex: male and female;
* body weight: Male ≥ 50 kg,female ≥ 45 kg, body mass index BMI (weight (kg)/height 2 (m2)) between 19-26 kg/m2 (including border);
* Healthy as judged by the investigator/subinvestigator based on the results of physical examinations and all lab tests;
* Abstinence or physical contraception approved by researchers must be approved during and within three months after the trial is completed; and no sperm and egg donation plan is available；
* Written informed consent;
Exclusion Criteria:
* Received any investigational drugs within 14 days before the screening test;
* Donated 200 mL of whole blood within 30 days before the screening test,or donated 200 mL of whole blood during the study or within 30 days after completion of the study;
* Females who are lactating, pregnant, potentially child-bearing, or willing to get pregnant during the study period;
* History of drug or food allergies;
* Abnormal blood pressure or pulse，Abnormal laboratory tests;
* Participated in other clinical trials within 3 months before screening;
* Smoking and drinking within 3 months before screening or test results of smoke, alcohol, and drug abuse are positive;
* Positive for HBsAg, Hepatitis C virus (HCV) antibody, HIV antibody or syphilis antibody;
* Clinically apparent disease/infection within 1 month before screening;
* The researchers determined that there were other conditions that were not suitable for the trial;
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT04126668
Study Brief:
Protocol Section:
NCT04126668