SchizophreniaPhase 1NCT07230652
A Phase 1 MAD Study to Evaluate the Safety and Tolerability of LY03020
A Phase 1 study testing LY03020 in people with Schizophrenia and Alzheimer's Disease Psychosis, run by Luye Pharma Group Ltd. at 1 site in China.
Trial summary
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 more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Alzheimer's Disease Psychosis
- What is being tested?
- LY03020
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2025to 28 Feb 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing AnDing Hospital Capital Medical University
Beijing
Anning Li, 86+13141209427, anning.li@hotmail.com
About this study
Official title: 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.
- Conditions
- Schizophrenia, Alzheimer's Disease Psychosis
- Being tested
- LY03020, Placebo
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY03020Drug
administered orally
PlaceboDrug
administered orally
| Study group | Role | What they receive |
|---|---|---|
| LY03020 | Experimental | Subjects will take LY03020 from Day 1 to Day 7 Receives: Drug: LY03020 |
| Placebo | Placebo comparator | Subjects will take Placebo from Day 1 to Day 7 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs) and serious adverse events (SAEs).
Measured: up to Day 11
Secondary outcomes (16)
Number of participants with clinical laboratory assessment abnormalities.
Measured: up to Day 11
Change from Baseline in Positive and Negative Syndrome Scale (PANSS) at Day 11 of subjects with stable schizophrenia
The total score range is 30 to 210.A higher score is associated with greater illness severity.
Measured: up to Day 11
Change from Baseline in Columbia - Suicide Severity Rating Scale (C-SSRS) at Day 11 of subjects with stable schizophrenia
This scale is divided into three parts, which are evaluated suicidal ideation(5 items [yes/no])，intensity of ideation (5 items on 5-point scales; scores range from 0 to 25 with higher scores indicating more intense suicidal ideation),and suicide behavior(actual attempt,interrupted attempt,aborted attempt, preparatory acts or behavior).
Measured: up to Day 11
Change from Baseline in Barnes Akathisia Rating Scale (BARS) at Day4 and Day 11 of subjects with stable schizophrenia
The total score range is 0 to 14.A higher score is associated with greater illness severity.
Measured: up to Day 11
Change from Baseline in Simpson-Angus Scale (SAS) at Day4 and Day 11 of subjects with stable schizophrenia
This scale consists of 10 items, and each question is scored from 0 to 4 points. The Total score range is 0 to 40.A higher score is associated with greater illness severity.
Measured: up to Day 11
Maximum observed concentration at steady state (Cmax,ss) of LPM787000048 in plasma
Measured: up to Day 11
Minimum observed concentration at steady state (Cmin,ss) of LPM787000048 in plasma
Measured: up to Day 11
Area under the concentration- time curve during the dosing interval at steady state (AUC0-τ,ss) of LPM787000048 in plasma
Measured: up to Day 11
Area under the concentration-time curve from time zero extrapolated to infinity at steady state (AUC0-∞,ss) of LPM787000048 in plasma
Measured: up to Day 11
Time to maximum observed concentration at steady (Tmax,ss) state of LPM787000048 in plasma
Measured: up to Day 11
Apparent terminal elimination half-life (t1/2) of LPM787000048 in plasma
Measured: up to Day 11
AUC Accumulation Ratio (Ra(AUC)) of LPM787000048 in plasma
Measured: up to Day 11
Cmax Accumulation Ratio (Ra(Cmax)) of LPM787000048 in plasma
Measured: up to Day 11
Number of participants with vital sign abnormalities.
Measured: up to Day 11
Number of participants with 12-lead electrocardiogram abnormalities (ECGs).
Measured: up to Day 11
Number of participants with ophthalmic examination abnormalities.
Measured: up to Day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start20 Aug 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luye Pharma Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07230652
- Sponsor's protocol ID
- LY03020/CT-CHN-103
- Status last verified
- Nov 2025
- First submitted
- 6 Aug 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No