NCT07292233 · Phase 1 · ACTIVE NOT RECRUITING
A Food Effect Study of LY03020 in Healthy Subjects
This trial is testing how food affects the absorption of a drug called LY03020 in healthy volunteers. Participants take a single dose twice — once with food, once without — so researchers can compare how the body processes the drug each way. It is a Phase 1 study, meaning this is early-stage work focused on basic drug behavior in the body, not on treating any condition yet.
You may qualify if
- 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.
You're excluded if
- 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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-12-18