RecruitingPhase 1NCT07230652

A Phase 1 MAD Study to Evaluate the Safety and Tolerability of LY03020

A Randomized, Double-Blind, Placebo-Controlled, Dose- Ascending Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of LPM787000048 Maleate Extended-Release Tablets (LY03020) in Chinese Adult Healthy Subjects and/or Subjects With Stable Schizophrenia


Sponsor

Luye Pharma Group Ltd.

Enrollment

40 participants

Start Date

Aug 20, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a randomized, double-blind, placebo-controlled, ascending multiple oral dose study to assess the safety, tolerability, and pharmacokinetics of LY03020 in Chinese healthy adult subjects and/or subjects with stable schizophrenia.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This early-phase safety study is testing a new drug called LY03020, which is a long-acting injectable medication being developed for schizophrenia. The study includes both healthy volunteers and people with stable schizophrenia to evaluate safety and how the drug behaves in the body. **You may be eligible if...** - You are between 18 and 45 years old (healthy volunteers) or 18 to 60 years old (people with schizophrenia) - For schizophrenia participants: your condition is currently stable and well-managed - Your weight and BMI are within acceptable ranges for the study - You are willing to follow all study procedures **You may NOT be eligible if...** - You have active, uncontrolled psychiatric illness (for healthy volunteers) - You have other significant medical conditions - You are pregnant or breastfeeding - You have a history of serious drug or alcohol problems - You have taken certain other medications recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLY03020

administered orally

DRUGPlacebo

administered orally


Locations(1)

Beijing AnDing Hospital Capital Medical University

Beijing, China

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NCT07230652


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