SchizophreniaPhase 1NCT07292233
A Food Effect Study of LY03020 in Healthy Subjects
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, open-label, single-dose, two-period, crossover study to assess the food effect on pharmacokinetics (PK) and safety of LY03020 in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 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?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2025to 30 Mar 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects sign informed consent voluntarily.
- Male or female aged 18 to 45 years.
- Body weight ≥ 50.0kg for male and ≥ 45.0kg for female, and body mass index (BMI) between 18.5 and 26.0 kg/m2.
Who cannot join
- 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 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.
Show all 9Show fewer
- Subjects have used any of nonprescription drugs within 7 days or prescription drugs within 28 days prior to first dosing.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label, Single-Dose, Two-Period, Crossover Phase I Clinical Study to Evaluate the Food Effect on the Pharmacokinetics of LPM787000048 Maleate Extended-Release Tablets (LY03020) in Healthy Subjects
This is a randomized, open-label, single-dose, two-period, crossover study to assess the food effect on pharmacokinetics (PK) and safety of LY03020 in healthy subjects.
- Conditions
- Schizophrenia, Alzheimer's Disease Psychosis
- Being tested
- LY03020
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY03020Drug
single dose，administered orally for each period
| Study group | Role | What they receive |
|---|---|---|
| fasted,fed | Experimental | Subjects will take LY03020 80mg under fasted conditions and after a standard high-fat breakfast in period 1 and 2 respectively. Receives: Drug: LY03020 |
| fed,fasted | Experimental | Subjects will take LY03020 80mg after a standard high-fat breakfast and under fasted conditions in period 1 and 2 respectively. Receives: Drug: LY03020 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration (Cmax) of LPM787000048 in plasma
Measured: up to Day 12
Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of LPM787000048 in plasma
Measured: up to Day 12
Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC0-t) of LPM787000048 in plasma
Measured: up to Day 12
Secondary outcomes (3)
Time to maximum observed concentration (Tmax) of LPM787000048 in plasma
Measured: up to Day 12
Apparent terminal elimination half-life (t1/2) of LPM787000048 in plasma
Measured: up to Day 12
Number of participants with adverse events (AEs).
Measured: up to Day 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start30 Jul 2025
- Primary completion27 Aug 2025
- Study completion30 Mar 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.
- More trials run by Luye Pharma Group Ltd.The sponsor's other registered studies.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
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
- NCT07292233
- Sponsor's protocol ID
- LY03020/CT-CHN-102
- Status last verified
- Dec 2025
- First submitted
- 6 Aug 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Single-Dose, Two-Period, Crossover Phase I Clinical Study to Evaluate the Food Effect on the Pharmacokinetics of LPM787000048 Maleate Extended-Release Tablets (LY03020) in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07292233
- Acronym / sponsor ID
- LY03020/CT-CHN-102
- Conditions
- Schizophrenia, Alzheimer's Disease Psychosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Luye Pharma Group Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 27 Aug 2025 (actual)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, open-label, single-dose, two-period, crossover study to assess the food effect on pharmacokinetics (PK) and safety of LY03020 in healthy subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fasted,fed | Experimental | Drug: LY03020Subjects will take LY03020 80mg under fasted conditions and after a standard high-fat breakfast in period 1 and 2 respectively. |
| fed,fasted | Experimental | Drug: LY03020Subjects will take LY03020 80mg after a standard high-fat breakfast and under fasted conditions in period 1 and 2 respectively. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects sign informed consent voluntarily.
- Male or female aged 18 to 45 years.
- Body weight ≥ 50.0kg for male and ≥ 45.0kg for female, and body mass index (BMI) between 18.5 and 26.0 kg/m2.
Key exclusion criteria (9 listed)
- 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 had a history of surgery within 3 months prior to administration, or had not recovered, or have a surgical plan during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY03020single dose，administered orally for each period | Drug | fasted,fed, fed,fasted |
Primary outcome
Maximum observed concentration (Cmax) of LPM787000048 in plasma
Time frame: up to Day 12
Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of LPM787000048 in plasma
Time frame: up to Day 12
Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC0-t) of LPM787000048 in plasma
Time frame: up to Day 12
3 secondary outcomes
Time to maximum observed concentration (Tmax) of LPM787000048 in plasma
Time frame: up to Day 12
Apparent terminal elimination half-life (t1/2) of LPM787000048 in plasma
Time frame: up to Day 12
Number of participants with adverse events (AEs).
Time frame: up to Day 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed concentration (Cmax) of LPM787000048 in plasma (time frame: up to Day 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.