RecruitingPhase 1

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

Lead sponsor

Luye Pharma Group Ltd.

Asset

LY03020

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease

Key I/E criterion

•Healthy volunteers

Primary endpoint

•Adverse events (AEs) and serious adverse events (SAEs)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDLY03020/CT-CHN-103

NCT IDNCT07230652

Timeline

Milestones

Study start2025-08-20actual

Study first posted2025-11-17actual

Last update posted2025-11-19actual

Primary completion2025-12-31estimated

Study completion2026-02-28estimated

Assets

Drug assets

LY03020

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

Maximum age60 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

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

Exclusion criteria

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.

•Congenital long QT syndrome; uncontrolled or severe cardiovascular disease, including NYHA class II or higher congestive heart failure, unstable angina, myocardial infarction within 6 months prior to screening, or presence of treatment-requiring severe arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes) at screening; resting heart rate <50 beats per minute (bpm) at screening/baseline; or QTc >450 ms (male) / QTc >460 ms (female) based on Fridericia's formula-corrected measurements at screening/baseline.

•Subjects with a history of orthostatic hypotension or syncope.

Endpoints (17)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Other (unclassified)

Behavior / neuropsychiatric

1 endpoint

Secondary/protocol endpoint

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

Time frame:up to Day 11

change from baseline, improvement

Safety / tolerability / PK

8 endpoints

Primary/protocol endpoint

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

Time frame:up to Day 11

event count, event

Secondary/protocol endpoint

Maximum observed concentration at steady state (Cmax,ss) of LPM787000048 in plasma

Time frame:up to Day 11

concentration, descriptive

Secondary/protocol endpoint

Time to maximum observed concentration at steady (Tmax,ss) state of LPM787000048 in plasma

Time frame:up to Day 11

time to event, event

Secondary/protocol endpoint

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

Time frame:up to Day 11

concentration, descriptive

Secondary/protocol endpoint

AUC Accumulation Ratio (Ra(AUC)) of LPM787000048 in plasma

Time frame:up to Day 11

concentration, descriptive

Secondary/protocol endpoint

Cmax Accumulation Ratio (Ra(Cmax)) of LPM787000048 in plasma

Time frame:up to Day 11

concentration, descriptive

Secondary/protocol endpoint

Number of participants with vital sign abnormalities.

Time frame:up to Day 11

event count, event

Secondary/protocol endpoint

Number of participants with 12-lead electrocardiogram abnormalities (ECGs).

Time frame:up to Day 11

event count, event