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Clinical Trials in China / NCT07292233
Active, not recruiting Phase 1

A Food Effect Study of LY03020 in Healthy Subjects

NCT07292233 · tracked via the Priya Life Science China tracker
Sponsor
Luye Pharma Group Ltd.
Phase
Phase 1
Started
2025-07-30
Last updated
2025-12-18

Condition(s) studied

SchizophreniaAlzheimer's Disease Psychosis

Investigational drug(s) / intervention(s)

LY03020

LY03020: single dose,administered orally for each period

Study summary

This is a randomized, open-label, single-dose, two-period, crossover study to assess the food effect on pharmacokinetics (PK) and safety of LY03020 in healthy subjects.

Eligibility

Sex
ALL
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Beijing AnDing Hospital Capital Medical University Beijing China

More Luye Pharma Group Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07292233 on ClinicalTrials.gov ↗ ← All trials in China