CompletedPhase 1

A Study Assessing the Safety and Tolerability of LY03020 in Chinese Healthy Subjects

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

Lead sponsor

Luye Pharma Group Ltd.

Asset

LY03020

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age 18-45

Primary endpoint

•Adverse events (AEs)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDLY03020/CT-CHN-101

NCT IDNCT06556966

Timeline

Milestones

Study first posted2024-08-16actual

Study start2024-08-19actual

Primary completion2025-02-13actual

Study completion2025-02-13actual

Last update posted2025-05-29actual

Assets

Drug assets

LY03020

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

Maximum age45 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•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)

Exclusion criteria

•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.

Endpoints (9)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Other (unclassified)

Safety / tolerability / PK

8 endpoints

Primary/protocol endpoint

Frequency of adverse events (AEs)

Time frame:up to144 hours

threshold achievement, event

Secondary/protocol endpoint

Maximum observed concentration (Cmax) of LPM787000048 in plasma

Time frame:up to144 hours

concentration, descriptive

Secondary/protocol endpoint

Time to maximum observed concentration (Tmax) of LPM787000048 in plasma

Time frame:up to144 hours

time to event, event

Secondary/protocol endpoint

Area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of LPM787000048 in plasma

Time frame:up to144 hours

concentration, descriptive

Secondary/protocol endpoint

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

concentration, descriptive

Secondary/protocol endpoint

Apparent terminal elimination half-life (t1/2) of LPM787000048 in plasma

Time frame:up to144 hours

concentration, descriptive

Secondary/protocol endpoint

Apparent volume of distribution（Vz/F） of LPM787000048 in plasma

Time frame:up to144 hours

descriptive

Secondary/protocol endpoint

Apparent total body clearance (CL/F) of LPM787000048 from plasma

Time frame:up to144 hours

descriptive

Other (unclassified)

1 endpoint

Other/protocol endpoint/low confidence

Quantitatively determine the concentration of LPM787000048 and major metabolites (if applicable) in urine and calculate the cumulative excretion ratio in urine.

Time frame:up to144 hours

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.