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 @ 2:50 AM
Ignite Modification Date:
2025-12-25 @ 2:50 AM
NCT ID:
NCT07292233
Eligibility Criteria:
Inclusion Criteria:
* Subjects sign informed consent voluntarily.
* Male or female aged 18 to 45 years.
* Body weight ≥ 50.0kg for male and ≥ 45.0kg for female, and body mass index (BMI) between 18.5 and 26.0 kg/m2.
Exclusion Criteria:
* Subjects have any clinically significant medical condition or chronic disease.
* Subjects experienced a history of keratopathy, fundus disease, increased intraocular pressure, or angle-closure glaucoma. Subjects have any abnormal and clinically significant test for ophthalmic examination during screening.
* Subjects with a history of orthostatic hypotension or syncope.
* Subjects with condition that may interfere with the drug absorption, distribution, metabolism and excretion significantly.
* Subjects had a history of surgery within 3 months prior to administration, or had not recovered, or have a surgical plan during the study.
* Subjects have any clinically significant abnormal vital signs, laboratory values, and ECGs.
* Subjects have used any of nonprescription drugs within 7 days or prescription drugs within 28 days prior to first dosing.
* Subjects have a history of allergic diseases, or allergic to any substance contained in the formulation.
* Subjects have a positive test for HBsAg, HCV-Ab, HIV-Ab, or syphilis antibody.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT07292233
Study Brief:
Protocol Section:
NCT07292233