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 @ 1:03 PM
Ignite Modification Date:
2025-12-24 @ 1:03 PM
NCT ID:
NCT06294561
Eligibility Criteria:
Inclusion Criteria:
* healthy subject; male or female
* Age between 18 and 45 (inclusive)
* body mass index (BMI) between 19.0 and 26.0 (inclusive)
* agree to consent
* able to communicate with investigator well and complete the study according to study protocol
Exclusion Criteria:
* abnormal and clinically significant test results (including physical exam, laboratory tests, 12-lead ECG, chest x-ray, etc.)
* any one positive result for hepatitis-B surface antigen, Hepatitis C antibody, HIV antibody or syphilis antibody
* prolongation in QT interval
* use of substance that affects CYP3A4 enzyme activity with 30 days before screening
* use of any drug within 14 days of test article administration
* use of any investigational drug or participation of any clinical study within 3 months before screening
* vaccination within 14 days before first test article administration, or have plans to receive vaccination during the study period
* history of cardiovascular diseases
* history of mental conditions including depression, aggressive behaviours, epilepsy, etc.
* history of major surgery within 6 months before screen, or have unhealed surgical wounds.
* any clinically significant conditions that investigator believes could affect study outcomes
* history of allergic reactions, or allergic to any components to the study drugs, or have food allergy/special requirement for food that forbids the subject to follow food requirements for the study
* daily cigarette consumption of more than 5 within 3 months before screening, or cannot avoid using cigarette/tabacco products during the study
* history of alcohol abuse (more than 14 units of alcohol per week) within 3 months before screening, or alcohol breath test of \> 0.0 mg/dl at screening
* history of substance abuse, or positive drug results at screening
* history of certain food intake 2 weeks before screening, and/or use of more than 8 cups of tea/coffee/grapefruit juice
* positive pregnancy test results, or pregnant/breast-feeding females
* history of unprotected sexual activities within 1 month before screening
* have plans for child bearing during study period and for 6 months after study, or disagree to take contraceptive measures during study period and for 6 months after study
* history of blood donation or blood loss within 3 months before screening, or have plans to donate blood within 1 month after the study
* any reasons that is deemed unsuitable for study participation as determined by investigator
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT06294561
Study Brief:
Protocol Section:
NCT06294561