SchizophreniaPhase 1NCT06556966
A Study Assessing the Safety and Tolerability of LY03020 in Chinese 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 single-center, randomized, double-blind, placebo-controlled, ascending single oral dose study to assess the safety, tolerability, and pharmacokinetics of LY03020 in Chinese healthy adult 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?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteChina
- Study dates
- 19 Aug 2024to 13 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 ≥ 50.0 kg for male and ≥ 45.0 kg for female, and male or female greater than or equal to 18.5 but less than 26.0 kg/m2 of body mass index (BMI).
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 a abnormal and clinically significant test for ophthalmic examination during screening.
- 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.
- Subjects have used any of nonprescription drugs within 7 days or prescription drugs within 28 days prior to administration.
- 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 serum reaction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ⅰ, Randomized, Double-blind, Placebo-controlled, Single Dose Ascending Study to Assess the Safety, Tolerability, and Pharmacokinetics of LPM787000048 Maleate Sustained-release Tablet (LY03020) in Chinese Healthy Adult Subjects
This is a single-center, randomized, double-blind, placebo-controlled, ascending single oral dose study to assess the safety, tolerability, and pharmacokinetics of LY03020 in Chinese healthy adult subjects.
Read the detailed description
The study will set 2.5mg, 5mg, 10mg, 20mg, 40mg, 60mg, 80mg and 100mg, a total of 8 dose groups. Qualified subjects were enrolled in site at D-1 ( 1 day before administration ) and randomized.The subjects should fast for at least 10 hours before medication administration, with no restrictions on water intake. The subjects will be required to orally take LY03020 or a placebo on an empty stomach upon waking on D1 (the day of medication administration). From D1 to D7, they will undergo safety assessments and PK biological sample collection.
- 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
Also called LPM787000048 Maleate sustained-release tablet
LY03020 for one single dose
PlaceboDrug
Also called Placebo of LPM787000048 Maleate sustained-release tablet
Placebo for one single dose
| Study group | Role | What they receive |
|---|---|---|
| LY03020 | Experimental | Subjects will take single-dose LY03020 on Day 1 Receives: Drug: LY03020 |
| Placebo | Sham comparator | Subjects will take single-dose Placebo on Day 1 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of adverse events (AEs)
Percentage of adverse events
Measured: up to144 hours
Secondary outcomes (7)
Maximum observed concentration (Cmax) of LPM787000048 in plasma
Subject blood samples will be collected at 17 time points and pharmacokinetic parameters will be calculated.
Measured: up to144 hours
Time to maximum observed concentration (Tmax) of LPM787000048 in plasma
Subject blood samples will be collected at 17 time points and pharmacokinetic parameters will be calculated.
Measured: up to144 hours
Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of LPM787000048 in plasma
Subject blood samples will be collected at 17 time points and pharmacokinetic parameters will be calculated.
Measured: up to144 hours
Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC0-t) of LPM787000048 in plasma
Subject blood samples will be collected at 17 time points and pharmacokinetic parameters will be calculated.
Measured: up to144 hours
Apparent terminal elimination half-life (t1/2) of LPM787000048 in plasma
Subject blood samples will be collected at 17 time points and pharmacokinetic parameters will be calculated.
Measured: up to144 hours
Apparent volume of distribution（Vz/F） of LPM787000048 in plasma
Subject blood samples will be collected at 17 time points and pharmacokinetic parameters will be calculated.
Measured: up to144 hours
Apparent total body clearance (CL/F) of LPM787000048 from plasma
Subject blood samples will be collected at 17 time points and pharmacokinetic parameters will be calculated.
Measured: up to144 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start19 Aug 2024
- Primary completion13 Feb 2025
- Study completion13 Feb 2025
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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luye Pharma Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gang Wang, Principal investigator, Beijing AnDing Hospital Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556966
- Sponsor's protocol ID
- LY03020/CT-CHN-101
- Status last verified
- May 2025
- First submitted
- 13 Aug 2024
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅰ, Randomized, Double-blind, Placebo-controlled, Single Dose Ascending Study to Assess the Safety, Tolerability, and Pharmacokinetics of LPM787000048 Maleate Sustained-release Tablet (LY03020) in Chinese Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT06556966
- Acronym / sponsor ID
- LY03020/CT-CHN-101
- Conditions
- Schizophrenia, Alzheimer's Disease Psychosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Luye Pharma Group Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 13 Feb 2025 (actual)
- Study completion
- 13 Feb 2025 (actual)
- First posted
- 16 Aug 2024 (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 single-center, randomized, double-blind, placebo-controlled, ascending single oral dose study to assess the safety, tolerability, and pharmacokinetics of LY03020 in Chinese healthy adult subjects.
Detailed description
The study will set 2.5mg, 5mg, 10mg, 20mg, 40mg, 60mg, 80mg and 100mg, a total of 8 dose groups. Qualified subjects were enrolled in site at D-1 ( 1 day before administration ) and randomized.The subjects should fast for at least 10 hours before medication administration, with no restrictions on water intake. The subjects will be required to orally take LY03020 or a placebo on an empty stomach upon waking on D1 (the day of medication administration). From D1 to D7, they will undergo safety assessments and PK biological sample collection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY03020 | Experimental | Drug: LY03020Subjects will take single-dose LY03020 on Day 1 |
| Placebo | Sham comparator | Drug: PlaceboSubjects will take single-dose Placebo on Day 1 |
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 ≥ 50.0 kg for male and ≥ 45.0 kg for female, and male or female greater than or equal to 18.5 but less than 26.0 kg/m2 of body mass index (BMI).
Key exclusion criteria (8 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 a abnormal and clinically significant test for ophthalmic examination during screening.
- 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.
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 |
|---|---|---|
| LY03020Also: LPM787000048 Maleate sustained-release tabletLY03020 for one single dose | Drug | LY03020 |
| PlaceboAlso: Placebo of LPM787000048 Maleate sustained-release tabletPlacebo for one single dose | Drug | Placebo |
Primary outcome
Frequency of adverse events (AEs)
Time frame: up to144 hours
Percentage of adverse events
7 secondary outcomes
Maximum observed concentration (Cmax) of LPM787000048 in plasma
Time frame: up to144 hours
Time to maximum observed concentration (Tmax) of LPM787000048 in plasma
Time frame: up to144 hours
Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of LPM787000048 in plasma
Time frame: up to144 hours
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 to144 hours
Apparent terminal elimination half-life (t1/2) of LPM787000048 in plasma
Time frame: up to144 hours
Apparent volume of distribution（Vz/F） of LPM787000048 in plasma
Time frame: up to144 hours
Apparent total body clearance (CL/F) of LPM787000048 from plasma
Time frame: up to144 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Individual participant dataSharing planned: No
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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.
Gang Wang principal investigator
Beijing AnDing Hospital Capital Medical University
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 8 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: finished, as of the sponsor's last update on 29 May 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Frequency of adverse events (AEs) (time frame: up to144 hours). 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 29 May 2025.