RecruitingPhase 1

A Study of HDM1002 Tablets on Cardiac Repolarization in Healthy Subjects

A Phase I, Single-center, Randomized, Double-blind, Placebo- and Positive-controlled, Four-period, Crossover Clinical Study to Evaluate the Effect of HDM1002 Tablets on Cardiac Repolarization in Healthy Subjects

Lead sponsor

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Asset

HDM1002

Oral · GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

Study population

Healthy volunteers

Eligibility highlights

•BMI 19-28

Primary endpoint

•Plasma concentration (steady state)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07594847

Org study IDHDM1002-110

Timeline

Milestones

Study start2026-03-07actual

Study first posted2026-05-19actual

Last update posted2026-05-19actual

Primary completion2026-09-25estimated

Study completion2026-11-06estimated

Assets

Investigational agents

HDM1002

Who this study enrolls

Healthy volunteers

Who can enroll

Minimum age18 Years

Maximum age45 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•The subject has voluntarily signed a written informed consent form.

•Male or female; age between 18 and 45 years (inclusive).

•Subject's weight ≥50 kg, with a body mass index (BMI) between 19.0 and 28.0 kg/m2, inclusive. BMI = weight (kg) / height2 (m2).

•Medical history inquiry, physical examination, laboratory test items, and other trial-related tests at screening are all normal or show mild abnormalities with no clinical significance, and the subject is judged to be eligible by the clinical research physician.

•The subject is able to communicate well with the investigator and comply with the protocol requirements to complete the study.

Exclusion criteria

•History of or current neurological/psychiatric, respiratory, cardiovascular, gastrointestinal, hematological and lymphatic, endocrine, or musculoskeletal system diseases, hepatic or renal insufficiency, or any other disease or physiological condition that may affect the study results;

•Subjects with a personal or family history of medullary thyroid cancer (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2);

•History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to screening;

•History of a cholecystitis episode within 3 months prior to screening;

•History of allergy to HDM1002, moxifloxacin hydrochloride tablets, other fluoroquinolones or quinolones, or any of the excipients; or history of food allergy, or a specific allergy history (asthma, urticaria, eczema, etc.);

•Clinically significant major illness or undergone major surgery within 3 months prior to the trial;

•Blood donation within 3 months, or plans to donate blood during this study, or transfusion or blood loss ≥200 mL within 4 weeks prior to the trial;

•Has consumed a special diet, engaged in strenuous exercise, or had other factors that affect drug absorption, distribution, metabolism, and excretion within 48 hours prior to dosing;

•Pregnant or lactating, or has a positive blood pregnancy test result;

•The investigator believes that the subject has any other condition that makes them unsuitable for participation in this clinical trial.

Endpoints (3)

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.

Safety / tolerability / PK

3 endpoints

Primary/protocol endpoint

Correlation between HDM1002 Plasma Concentration and ΔΔQTc

Time frame:From the base line ECG (Day -1) to end of the period, up to 48 hours post-dose

Plasma concentration (steady state)

descriptive

Secondary/protocol endpoint

Categorical outliers for QTc, HR, PR, and QRS

Time frame:From the base line ECG (Day -1) to end of the period, up to 48 hours post-dose

categorical status, event

componentsqt corrected interval outlier, heart rate outlier, pr interval outlier, qrs duration outlier

Secondary/protocol endpoint

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

Time frame:25 days

Treatment-emergent AEs (any)

event count, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

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 6, 2026 snapshot.