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

NCT07230652 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-11-19

No results posted yet for this study

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.

Conditions

Interventions

DRUG

LY03020

administered orally

DRUG

Placebo

administered orally

Sponsors & Collaborators

  • Luye Pharma Group Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-20
Primary Completion
2025-12-31
Completion
2026-02-28
FDA Drug
Yes

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07230652 on ClinicalTrials.gov