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
| Registry | NCT07230652 |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
| Enrollment | 40 (Estimated) |
| Sponsor | Luye Pharma Group Ltd. (Industry) |
| Conditions | Schizophrenia, Alzheimer's Disease Psychosis |
| Interventions | LY03020, Placebo (Drug) |
| Dates | start 2025-08-20, primary completion 2025-12-31 (estimated), completion 2026-02-28 (estimated), first posted 2025-11-17, last updated 2025-11-19 |
| Locations | 1 site in China |
Related Papers Related Patents Related Grants Related Experts
All trials for Schizophrenia All trials for Alzheimer's Disease Psychosis All trials of LY03020 All trials of Placebo
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| LY03020 | Experimental | Drug: LY03020 | Subjects will take LY03020 from Day 1 to Day 7 |
| Placebo | Placebo comparator | Drug: Placebo | Subjects will take Placebo from Day 1 to Day 7 |
Sex: All, ages: 18 Years to 60 Years, accepts healthy volunteers
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.| Facility | City | Country | Status |
|---|---|---|---|
| Beijing AnDing Hospital Capital Medical University | Beijing | China | Recruiting |