Actively Recruiting
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ascending Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of LY03020 in Chinese Healthy Adults and Adults With Stable Schizophrenia
Led by Luye Pharma Group Ltd. · Updated on 2025-11-19
40
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying LY03020, an oral drug, to understand its safety, tolerability, and how it is processed by the body in healthy Chinese adults and adults with stable schizophrenia. This randomized, double-blind, placebo-controlled Phase 1 study aims to carefully evaluate these factors in both healthy participants and those with stable schizophrenia, including assessments of side effects and drug levels in the blood. Participants will be randomly assigned to receive either LY03020 or a placebo once daily from Day 1 to Day 7. The study includes close monitoring during this treatment period to observe effects and collect blood samples for pharmacokinetic analyses. The design includes multiple dose levels to assess how the drug behaves at different dosages. Throughout the study, participants will undergo various evaluations including safety monitoring for adverse events, vital signs, ECGs, and eye exams. For those with schizophrenia, mental health assessments like the Positive and Negative Syndrome Scale (PANSS) and suicide severity rating will be conducted. The study lasts up to Day 11 after dosing begins, allowing researchers to monitor participants closely for any changes or side effects.
CONDITIONS
Brief Title
A Phase 1 MAD Study to Evaluate the Safety and Tolerability of LY03020
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects must voluntarily sign informed consent.
- Healthy subjects aged 18 to 45 years; subjects with stable schizophrenia aged 18 to 60 years.
- Male subjects must weigh at least 50.0 kg; female subjects must weigh at least 45.0 kg.
- Healthy subjects must have a body mass index (BMI) between 18.5 and 26.0 kg/m2; subjects with stable schizophrenia must have a BMI between 18.5 and 32.0 kg/m2.
- Subjects with stable schizophrenia must meet DSM-V criteria for schizophrenia.
- Subjects with stable schizophrenia must have a PANSS total score of 80 or less and a CGI-S score of 4 or less at screening.
- Subjects with stable schizophrenia must have stable condition for at least 1 month before consent.
You will not qualify if you...
- Healthy subjects with any significant medical condition or chronic disease.
- Healthy subjects who used nonprescription drugs within 7 days or prescription drugs within 28 days before dosing.
- Subjects with history of keratopathy, fundus disease, increased intraocular pressure, or angle-closure glaucoma.
- Subjects with abnormal and significant ophthalmic exam findings during screening.
- Subjects with history of orthostatic hypotension or syncope.
- Subjects with conditions affecting drug absorption, metabolism, or elimination.
- Subjects with recent surgery within 3 months before dosing or planned surgery during the study.
- Subjects with significant abnormal vital signs, lab results, or ECGs.
- Subjects with allergic diseases or allergies to study drug components.
- Subjects positive for HBsAg, HCV-Ab, HIV-Ab, or syphilis antibody.
- Subjects with other mental disorders besides schizophrenia within 6 months before screening.
- Subjects with treatment-resistant schizophrenia or history of neuroleptic malignant syndrome.
- Subjects with recent suicide attempts or suicidal ideation within 6 months before screening.
- Subjects who used MAOI drugs within 28 days or dietary supplements/traditional Chinese herbal products within 7 days before dosing.
- Subjects with HbA1c equal or above 7% at screening.
- Subjects with congenital long QT syndrome or severe cardiovascular disease.
- Subjects with resting heart rate below 50 bpm or prolonged QTc interval.
- Subjects with history of significant eye diseases or symptoms as above.
- Subjects with history of orthostatic hypotension or syncope.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days
Participants take oral doses of LY03020 or placebo daily.
Daily visits or assessments during dosing from Day 1 to Day 7
Duration - Up to 4 days after dosing (up to Day 11)
Participants are monitored for safety and tolerability after treatment ends.
1 to 2 visits after dosing completion
Trial Site Locations
Total: 1 location
1
Beijing AnDing Hospital Capital Medical University
Beijing, China
Actively Recruiting
Research Team
Y
Yufeng Wang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here