Tests LY03020 safety in healthy adults and people with stable schizophrenia
Tests LY03020 tablets in adults with stable schizophrenia and healthy adults.
Plain-language title generated from the registry record
Registry title: A Phase 1 MAD Study to Evaluate the Safety and Tolerability of LY03020
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT07230652, who can take part
Where in China
- Beijing Anding Hospital, Capital Medical UniversityBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Luye Pharma Group Ltd.
- Trial code
- NCT07230652
- Record updated
- 19 November 2025
- Original description
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.Read full original descriptionShow less
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 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.
Inclusion: 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: Subjects have used any of nonprescription drugs within 7 days or prescription drugs within 28 days prior to administration; Subjects had a history of surgery within 3 months prior to administration, or had not recovered, or have a surgical plan during the study; According to the DSM-5, there were other mental disorders except schizophrenia within 6 months before screening period; 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; Subjects have any clinically significant medical condition or chronic disease; 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 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; 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 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 have any clinically significant abnormal vital signs, laboratory values, and ECGs; 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; Healthy Subjects.