A Study of HDM1002 Tablets on Cardiac Repolarization in Healthy Subjects

NCT07594847 | Recruiting Phase 1 FDA Drug

• 1 other identifier: HDM1002-110
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this trial is to evaluate the effect of a single oral dose of HDM1002 tablets on the QT/QTc interval in healthy subjects.

Conditions

Healthy Adult Subject

Outcome Measures

Primary Outcomes (1)

• Correlation between HDM1002 Plasma Concentration and ΔΔQTc

  HDM1002 plasma concentration in ng/mL measured by validated LC-MS/MS; ΔΔQTc in msec derived from Fridericia-corrected QT interval with baseline and placebo correction, using 12-lead ECG read centrally in a blinded manner.

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

Secondary Outcomes (2)

• Categorical outliers for QTc, HR, PR, and QRS

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

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

  25 days

Study Arms (4)

HDM1002 200 mg

EXPERIMENTAL

Drug: HDM1002 200 mg

HDM1002 400 mg

EXPERIMENTAL

Drug: HDM1002 400 mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Moxifloxacin

ACTIVE COMPARATOR

Drug: Moxifloxacin 400 mg

Interventions

HDM1002 200 mg DRUG

HDM1002 tablet, oral, 200 mg single dose

HDM1002 200 mg

HDM1002 400 mg DRUG

HDM1002 tablet, oral, 400 mg single dose

HDM1002 400 mg

Placebo DRUG

Placebo tablet, oral, single dose

Placebo

Moxifloxacin 400 mg DRUG

Moxifloxacin tablet, oral, 400 mg single dose

Moxifloxacin

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.: lead

Study Sites (1)

PKUcare Luzhong Hospital

Zibo, Shangdong, 255400, China

RECRUITING

MeSH Terms

Interventions

Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 19, 2026
• Study Start: March 7, 2026
• Primary Completion (Estimated): September 25, 2026
• Study Completion (Estimated): November 6, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)