RecruitingSchizophreniaAlzheimer's Disease Psychosis
A Phase 1 MAD Study to Evaluate the Safety and Tolerability of LY03020
Eligible age
18–60 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
Yes
See if you qualify for this study
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About this study
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.
Sponsor: Luye Pharma Group Ltd.
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.
Source: ClinicalTrials.gov · NCT07230652 · last updated 2025-11-19