Study of Food Effect on Pharmacokinetics of HMPL-523 Acetate Tablets

NCT07348133 | Completed Phase 1

• 1 other identifier: 2025-523-00CH2
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, open-label, randomized, three-period, six-sequence study to evaluate the effect of food (high-fat and low-fat) on the PK of HMPL-523. In this study, 18 healthy Chinese participants are planned to be enrolled, randomized in a ratio of 1:1:1:1:1:1 to one of 6 dosing sequences (see dosing sequence table for details), and administered once per cycle for 3 cycles, with a washout period of at least 7 days. The study consists of a screening/baseline period, a dosing period (three cycles), and a follow-up period.

Conditions

Healthy

Keywords

HMPL-523

Outcome Measures

Primary Outcomes (5)

• AUC0-t

  Area under the plasma concentration-time curve from time zero to the last time point t where the concentration could be accurately determined

  up to one months

• AUC0-∞

  Area under the plasma concentration-time curve from time 0 to infinity

  up to one months

• Cmax

  Maximum plasma concentration

  up to one months

• Tmax

  Other PK parameters of HMPL-523, such as time to Cmax

  up to one months

• t1/2

  Other PK parameters of HMPL-523, such as terminal elimination half-life

  up to one months

Secondary Outcomes (2)

• Adverse events rate

  up to one months

• Laboratory tests

  up to one months

Study Arms (6)

ABC

EXPERIMENTAL

The 3 cycles of each sequence consist of 3 dietary conditions, i.e., fasting (A), standard high-fat breakfast (B), and standard low-fat breakfast (C). Participants will receive a single oral dose of HMPL-523 acetate tablets 300 mg on Day 1 of each cycle.

Drug: HMPL-523

ACB

EXPERIMENTAL

The 3 cycles of each sequence consist of 3 dietary conditions, i.e., fasting (A), standard high-fat breakfast (B), and standard low-fat breakfast (C). Participants will receive a single oral dose of HMPL-523 acetate tablets 300 mg on Day 1 of each cycle.

Drug: HMPL-523

BAC

EXPERIMENTAL

The 3 cycles of each sequence consist of 3 dietary conditions, i.e., fasting (A), standard high-fat breakfast (B), and standard low-fat breakfast (C). Participants will receive a single oral dose of HMPL-523 acetate tablets 300 mg on Day 1 of each cycle.

Drug: HMPL-523

BCA

EXPERIMENTAL

The 3 cycles of each sequence consist of 3 dietary conditions, i.e., fasting (A), standard high-fat breakfast (B), and standard low-fat breakfast (C). Participants will receive a single oral dose of HMPL-523 acetate tablets 300 mg on Day 1 of each cycle.

Drug: HMPL-523

CAB

EXPERIMENTAL

The 3 cycles of each sequence consist of 3 dietary conditions, i.e., fasting (A), standard high-fat breakfast (B), and standard low-fat breakfast (C). Participants will receive a single oral dose of HMPL-523 acetate tablets 300 mg on Day 1 of each cycle.

Drug: HMPL-523

CBA

EXPERIMENTAL

The 3 cycles of each sequence consist of 3 dietary conditions, i.e., fasting (A), standard high-fat breakfast (B), and standard low-fat breakfast (C). Participants will receive a single oral dose of HMPL-523 acetate tablets 300 mg on Day 1 of each cycle.

Drug: HMPL-523

Interventions

HMPL-523 DRUG

The 3 cycles of each sequence consist of 3 dietary conditions, i.e., fasting (A), standard high-fat breakfast (B), and standard low-fat breakfast (C). Participants will receive a single oral dose of HMPL-523 acetate tablets 300 mg on Day 1 of each cycle.

ABC; ACB; BAC; BCA; CAB; CBA

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants can communicate well with the investigator, voluntarily sign the ICF, and agree to comply with the requirements of the study protocol;
• Male and female healthy participants aged 18-45 years (inclusive);
• Body weight ≥ 45 kg (females), or ≥ 50 kg (males), body mass index (BMI) 19-26 kg/m2 (inclusive);
• Participants must commit to using highly effective contraception for both themselves and their sexual partners during the study, and for 180 days after the end of the last study dose, and must not engage in sperm donation, egg donation, or have birth plan.

You may not qualify if:

• Abnormal and clinically significant results of vital signs, physical examination, 12-lead ECG, chest X-ray (frontal and lateral), laboratory tests (including hematology, blood chemistry, urinalysis, etc.) or serum creatinine above the upper limit of normal at screening;
• Positive for any of the HBsAg, HCV antibody, HIV antibody, or Treponema pallidum antibody;
• History or current evidence of severe or chronic metabolic/endocrine, hepatic, renal, hematological, pulmonary, immunological, cardiovascular, gastrointestinal, genitourinary, neurological or psychiatric diseases;
• Prior history of hypertension;
• Prior history of severe gastrointestinal diseases such as dysphagia, active gastric ulcers, etc., resulting in inability to take oral medication or disorders in absorption of oral medication
• Prior history of gastrointestinal surgery, renal surgery, cholecystectomy, etc. that, in the judgment of the investigator, may affect drug absorption or excretion;
• Prior history of drug allergy, or acute allergic rhinitis or food allergy within 2 weeks before screening, or allergy to the active ingredients or excipients of the study drug;
• Use of any prescription drugs and Chinese herbal medicines within 30 days prior to the first dose;
• Use of any over-the-counter drugs, vitamins, and health products within 14 days prior to the first dose;
• Consumption of more than 10 cigarettes per day within 3 months before screening, or those who cannot quit smoking during the study;
• Regular alcohol consumption within 6 months before screening, that is, those who drink more than 14 units of alcohol per week (1 unit = 360 mL of beer, or 45 mL of spirits with an alcohol content of 40%, or 150 mL of wine), or those who cannot abstain from alcohol during the study, or those who are positive for alcohol breath test;
• History of drug abuse or recreational use, or positive for urine drug abuse screen;
• Blood donation (including blood component donation) or blood loss ≥ 400 mL within 3 months prior to screening, use of blood products within 2 months prior to screening, blood donation (including component blood donation) or lost blood ≥ 200 mL within 1 month prior to screening, or a plan to donate blood or blood components during the study or within 1 month after the end of the study;
• Difficulty in blood collection, or a history of needle phobia or blood phobia, or intolerance to blood sampling via venipuncture, or poor evaluation of venous blood collection;
• Those who have participated in clinical trials of other drugs/medical devices and have taken study drugs within 3 months prior to screening;

Sponsors & Collaborators

• Hutchmed: lead

Study Sites (1)

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, 250014, China

Location

Study Officials

• Wei Zhao, Doctor

  Shandong First Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a single-center, open-label, randomized, three-period, six-sequence study. There are 3 cycles of dosing, and participants will be randomized to 1 of the 6 dosing sequences (ABC, ACB, BAC, BCA, CAB, or CBA). The 3 cycles of each sequence consist of 3 dietary conditions, i.e., fasting (A), standard high-fat breakfast (B), and standard low-fat breakfast (C). Participants will receive a single oral dose of HMPL-523 acetate tablets 300 mg on Day 1 of each cycle.

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: January 16, 2026
• Study Start: December 11, 2025
• Primary Completion: January 12, 2026
• Study Completion: February 6, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)