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

NCT07230652 | Recruiting Phase 1 FDA Drug

• 1 other identifier: LY03020/CT-CHN-103
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Schizophrenia; Alzheimer's Disease Psychosis

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events (AEs) and serious adverse events (SAEs).

  up to Day 11

Secondary Outcomes (16)

• Number of participants with clinical laboratory assessment abnormalities.

  up to Day 11

• Change from Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 11 of subjects with stable schizophrenia

  up to Day 11

• Change from Baseline in Columbia - Suicide Severity Rating Scale (C-SSRS) at Day 11 of subjects with stable schizophrenia

  up to Day 11

• Change from Baseline in Barnes Akathisia Rating Scale (BARS) at Day4 and Day 11 of subjects with stable schizophrenia

  up to Day 11

• Change from Baseline in Simpson-Angus Scale (SAS) at Day4 and Day 11 of subjects with stable schizophrenia

  up to Day 11

Study Arms (2)

LY03020

EXPERIMENTAL

Subjects will take LY03020 from Day 1 to Day 7

Drug: LY03020

Placebo

PLACEBO COMPARATOR

Subjects will take Placebo from Day 1 to Day 7

Drug: Placebo

Interventions

LY03020 DRUG

administered orally

LY03020

Placebo DRUG

administered orally

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Subjects
• Subjects sign informed consent voluntarily.
• Male or female aged 18 to 45 years.
• Body weight ≥ 50.0 kg for male and ≥ 45.0 kg for female, and body mass index (BMI) between 18.5 and 26.0 kg/m2 Subjects with Stable Schizophrenia
• Subjects themselves and / or their guardians sign informed consent voluntarily.
• Male or female aged 18 to 60 years.
• Body weight ≥ 50.0 kg for male and ≥ 45.0 kg for female, and body mass index (BMI) between 18.5 and 32.0 kg/m2.
• Subject must meet the DSM-V criteria for a primary diagnosis of schizophrenia. Subject must have a PANSS total score ≤ 80 and CGI-S score ≤ 4 at screening. The condition is stable from 1 month before signing informed consent to baseline.

You may not qualify if:

• Healthy Subjects
• Subjects have any clinically significant medical condition or chronic disease.
• Subjects have used any of nonprescription drugs within 7 days or prescription drugs within 28 days prior to administration.
• 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 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. Subjects with Stable Schizophrenia
• According to the DSM-5, there were other mental disorders except schizophrenia within 6 months before screening period.
• Assessed by the investigator as having treatment-resistant schizophrenia; past or current diagnosis of neuroleptic malignant syndrome (NMS); anticipated need for antipsychotic regimen modifications during the study period;
• History of suicide attempts (including actual attempts, interrupted attempts, or failed attempts) or suicidal ideation within the past 6 months, defined as affirmative responses ("yes") to question 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) at screening/baseline;
• Subjects have used monoamine oxidase inhibitors (MAOI) within 28 days or any dietary supplements/traditional Chinese herbal products within 7 days prior to first dosing.
• Glycated hemoglobin (HbA1c) ≥7% at screening/baseline.

Sponsors & Collaborators

• Luye Pharma Group Ltd.: lead

Study Sites (1)

Beijing AnDing Hospital Capital Medical University

Beijing, China

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Yufeng Wang

CONTACT

86+18665029373; wangyufeng@luye.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: November 17, 2025
• Study Start: August 20, 2025
• Primary Completion: December 31, 2025
• Study Completion: February 28, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)