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Active not recruitingPhase 1

A Food Effect Study of LY03020 in Healthy Subjects

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

Asset

LY03020

Listed sites

1

Recruiting sites

-

Enrollment

16

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age 18-45

Primary endpoints

•Cmax of LPM787000048 in plasma•AUC from time zero extrapolated to infinity (AUC0-∞) of LPM787000048 in plasma•AUC

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-102
NCT IDNCT07292233

Timeline

Milestones

Study start2025-07-30actual
Primary completion2025-08-27actual
Study first posted2025-12-18actual
Last update posted2025-12-18actual
Study completion2026-03-30estimated

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 ≥ 50.0kg for male and ≥ 45.0kg for female, and body mass index (BMI) between 18.5 and 26.0 kg/m2

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 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.
•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.

Endpoints (6)

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
4
Other (unclassified)
2

Safety / tolerability / PK

4 endpoints
Primary/protocol endpoint

Maximum observed concentration (Cmax) of LPM787000048 in plasma

Time frame:up to Day 12

concentration, descriptive

Secondary/protocol endpoint

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

Time frame:up to Day 12

time to event, event

Secondary/protocol endpoint

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

Time frame:up to Day 12

concentration, descriptive

Secondary/protocol endpoint

Number of participants with adverse events (AEs).

Time frame:up to Day 12

event count, event

Other (unclassified)

2 endpoints
Primary/protocol endpoint/low confidence

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

Time frame:up to Day 12

concentration, descriptive

Primary/protocol endpoint/low confidence

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

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.