Not yet recruitingPhase 1

Effect of Food and Age on the Pharmacokinetics of LY03017

A Phase 1 Study to Evaluate the Effect of Food and Age on the Pharmacokinetics of LPM526000133 Fumarate Capsules (LY03017) in Healthy Volunteers

Lead sponsor

Luye Pharma Group Ltd.

Asset

LY03017

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease

Key I/E criterion

•Age ≥18

Primary endpoints

•Cmax of LPM526000133 in plasma•AUC from time zero extrapolated to infinity (AUC0-∞) of LPM526000133 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 IDLY03017/CT-CHN-102

NCT IDNCT06793995

Timeline

Milestones

Study first posted2025-01-27actual

Last update posted2025-01-27actual

Study start2025-02estimated (month precision)

Primary completion2025-10-31estimated

Study completion2025-10-31estimated

Assets

Drug assets

LY03017

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Subject who voluntarily participate and sign the informed consent form.

•Part A：Age ≥18 and ≤ 45 years, male and female.

•Part B：Age ≥65 years, male and female.

•Body weight ≥ 50.0 kg for men and ≥ 45.0 kg for women, and body mass index (BMI) ≥18.5 and < 28.0 kg/m2.

•Able to comply with the lifestyle restrictions

Exclusion criteria

•Subject has a history of allergy to any component of the investigational drug or similar drugs, or allergic constitution.

•Part A：Subject has a history of clinically significant medical conditions that may interfere with the study results, including but not limited to blood system, circulatory system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, malignant tumors, mental disorders and metabolic disorders.

•Part B：Subject has a history of clinically significant medical conditions that may interfere with the study results, including but not limited to blood system, circulatory system, digestive system, urinary system, respiratory system, nervous system, immune system, endocrine system, malignant tumors, mental disorders and metabolic disorders. Subjects with well-controlled, chronic and stable medical conditions (e.g., hypertension, type 2 diabetes, hyperlipidaemia) which are not expected to compromise subject safety or interfere with the study results will not be excluded.

•Any surgical condition or condition may significantly affect the absorption, distribution, metabolism and excretion of the drug, or may pose a hazard to the subjects.

•Subject has clinically significant abnormalities in vital signs, laboratory tests, and ECGs, such as

1. Pulse < 55 beats/min or > 100 beats/min,

2. Systolic blood pressure < 90 mmHg or ≥140 mmHg, Diastolic blood pressure < 60 mmHg or ≥90 mmHg,

3. QT interval (QTc) ≥450 ms.

4. Part B：aspartate aminotransferase (AST) or alanine aminotransferase (ALT) or total bilirubin > 1.5 × upper limit normal (ULN), or estimated glomerular filtration rate（eGFR） <60 mL/min/1.73 m2

•Part A：Subject has used any of over-the-counter products within 7 days or prescription medications within 28 days prior to dosing.

•Part B：Subject has used any of over-the-counter products within 7 days or prescription medications within 28 days prior to dosing, with the exception of concomitant drugs for the well-controlled, chronic and stable medical conditions.

•Subject has a history of surgery within 3 months prior to administration, or failure to recover from surgery, or having an expected surgical plan during the trial.

•Subject positive for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-Ab), or syphilis seroreactivity (Trust).

•Subject has a history of alcohol abuse within 1 year or positive alcohol breath test results.

•Subject has a history of substance abuse within 1 year or a positive urine drug screen.

•Subject who has daily smoking of ≥ 5 cigarettes within 3 months.

•Subject who has special requirements for food, cannot comply with the unified diet or have dysphagia.

•Subject who has consumption of special diet (such as grapefruit, chocolate, coffee, xanthine-rich foods/drinks) within 48 hours prior to dosing and/or subject who has excessive daily consumption of tea, coffee, grapefruit juice, caffeinated beverages for nearly 3 months.

•Subject who has participated in other clinical trials within 3 months before administration.

•Subject has used blood products or being blood donor or blood loss within 3 months.

•Pregnant, lactating women, or positive pregnancy test.

•Subject who refusal to contraception, or plan to donate sperm or ovums.

•Subject who has a history of needle or blood faintness.

•Subject directly involved in this clinical trial.

•Poor compliance or other conditions which would make participation in the study unsuitable.

Endpoints (4)

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

3 endpoints

Primary/protocol endpoint

Maximum observed concentration (Cmax) of LPM526000133 in plasma

Time frame:Up to 96 hours after the last dose

concentration, descriptive

Primary/protocol endpoint

Area under the concentration-time curve from time zero to the time of last quantifiable concentration (AUC[0-last]) of LPM526000133 in plasma

Time frame:Up to 96 hours after the last dose

concentration, descriptive

Secondary/protocol endpoint

Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

Time frame:Up to 96 hours after the last dose

event count, event

Other (unclassified)

1 endpoint

Primary/protocol endpoint/low confidence

The area under the concentration-time curve from time zero extrapolated to infinity (AUC0-∞) of LPM526000133 in plasma

Time frame:Up to 96 hours after the last dose

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.