A Food Effect Study of LY03020 in Healthy Subjects

NCT07292233 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: LY03020/CT-CHN-102
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia; Alzheimer's Disease Psychosis

Outcome Measures

Primary Outcomes (3)

• Maximum observed concentration (Cmax) of LPM787000048 in plasma

  up to Day 12

• Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of LPM787000048 in plasma

  up to Day 12

• Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC0-t) of LPM787000048 in plasma

  up to Day 12

Secondary Outcomes (3)

• Time to maximum observed concentration (Tmax) of LPM787000048 in plasma

  up to Day 12

• Apparent terminal elimination half-life (t1/2) of LPM787000048 in plasma

  up to Day 12

• Number of participants with adverse events (AEs).

  up to Day 12

Study Arms (2)

fasted,fed

EXPERIMENTAL

Subjects will take LY03020 80mg under fasted conditions and after a standard high-fat breakfast in period 1 and 2 respectively.

Drug: LY03020

fed,fasted

EXPERIMENTAL

Subjects will take LY03020 80mg after a standard high-fat breakfast and under fasted conditions in period 1 and 2 respectively.

Drug: LY03020

Interventions

LY03020 DRUG

single dose，administered orally for each period

fasted,fed; fed,fasted

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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 may not qualify 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.

Sponsors & Collaborators

• Luye Pharma Group Ltd.: lead

Study Sites (1)

Beijing AnDing Hospital Capital Medical University

Beijing, China

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: December 18, 2025
• Study Start: July 30, 2025
• Primary Completion: August 27, 2025
• Study Completion: March 30, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)