Multiple-dose safety and tolerability test of LY03020 in healthy adults and people with stable schizophrenia

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

This test will see if taking repeated oral doses of LY03020 is safe and tolerated by healthy Chinese adults and people with stable schizophrenia.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Luye Pharma Group Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing)
• Trial ID: NCT07230652 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled, ascending multiple oral dose Phase 1 study will give LY03020 or placebo to cohorts of Chinese healthy adults and adults with stable schizophrenia to characterize safety, tolerability, and pharmacokinetics. Participants will be randomized and dosed in escalating cohorts with close monitoring for adverse events, vital signs, and laboratory measures. The trial includes healthy participants aged 18–45 and people with stable schizophrenia aged 18–60 who meet DSM-5 criteria and predefined stability and BMI requirements. Findings will inform safe dose ranges and guide planning of later efficacy trials.

Who should consider this trial

Good fit: Ideal candidates are Chinese adults who are either healthy (age 18–45) or have stable schizophrenia (age 18–60) meeting DSM-5 criteria with PANSS ≤80 and CGI-S ≤4 and within the specified BMI ranges.

Not a fit: People with unstable schizophrenia, significant medical conditions, recent use of disallowed medications, out-of-range BMI, or who cannot attend on-site visits are unlikely to receive benefit from participation.

Why it matters

Potential benefit: If successful, the trial could identify a safe dose range and tolerability profile for LY03020 to support further testing for psychosis symptoms.

How similar studies have performed: Multiple ascending-dose safety and pharmacokinetic trials are a standard first step and similar designs have enabled other psychiatric drugs to advance, but LY03020 itself is novel and has not yet demonstrated clinical efficacy.

Eligibility criteria

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 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.

Where this trial is running

Beijing

• Beijing AnDing Hospital Capital Medical University — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Yufeng Wang

Conditions Schizophrenia; Alzheimer's Disease Psychosis