Actively Recruiting
A Phase 1 MAD Study to Evaluate the Safety and Tolerability of LY03020
Led by Luye Pharma Group Ltd. · Updated on 2025-11-19
40
Participants Needed
1
Research Sites
27 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase 1 MAD Study to Evaluate the Safety and Tolerability of LY03020
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 45 years for healthy subjects
- Body weight 50 kg for males and 45 kg for females with BMI between 18.5 and 26.0 kg/m2 for healthy subjects
- Male or female aged 18 to 60 years for subjects with stable schizophrenia
- Body weight 50 kg for males and 45 kg for females with BMI between 18.5 and 32.0 kg/m2 for subjects with stable schizophrenia
- Subjects with stable schizophrenia must meet DSM-V criteria for schizophrenia
- Subjects with stable schizophrenia must have PANSS total score 80 and CGI-S score 4 at screening
- Condition must be stable from 1 month before informed consent to baseline
- Subjects or guardians must voluntarily sign informed consent
You will not qualify if you...
- Healthy subjects with any clinically significant medical condition or chronic disease
- Use of nonprescription drugs within 7 days or prescription drugs within 28 days prior to administration in healthy subjects
- History of keratopathy, fundus disease, increased intraocular pressure, or angle-closure glaucoma
- Abnormal and clinically significant ophthalmic test results during screening
- History of orthostatic hypotension or syncope
- Conditions significantly interfering with drug absorption, distribution, metabolism, or excretion
- Surgery within 3 months prior to administration, not recovered, or planned during the study
- Clinically significant abnormal vital signs, laboratory values, or ECGs
- History of allergic diseases or allergy to study drug substances
- Positive test for HBsAg, HCV-Ab, HIV-Ab, or syphilis antibody
- Subjects with stable schizophrenia with other mental disorders within 6 months before screening
- Treatment-resistant schizophrenia or history of neuroleptic malignant syndrome
- History of suicide attempts or suicidal ideation within past 6 months
- Use of MAOI within 28 days or dietary supplements/traditional Chinese herbal products within 7 days prior to dosing
- HbA1c 7% at screening/baseline
- Congenital long QT syndrome or severe cardiovascular disease
- Resting heart rate <50 bpm or prolonged QTc intervals at screening/baseline
- History of keratopathy, fundus disease, increased intraocular pressure, or angle-closure glaucoma
- History of orthostatic hypotension or syncope
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing AnDing Hospital Capital Medical University
Beijing, China
Actively Recruiting
Research Team
Y
Yufeng Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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