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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Adult Subject
• Intervention / Treatment: Drug: HDM1002 200 mg; Drug: HDM1002 400 mg; Drug: Placebo; Drug: Moxifloxacin 400 mg

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shangdong
    • Zibo, Shangdong, China, 255400
      • Recruiting
      • PKUcare Luzhong Hospital
      • Contact: Yan Gao; Phone Number: +86-0571-89918267; Email: cxygaoyan@eastchinapharm.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo tablet, oral, single dose
Active Comparator: Moxifloxacin	Drug: Moxifloxacin 400 mg; Moxifloxacin tablet, oral, 400 mg single dose
Experimental: HDM1002 200 mg	Drug: HDM1002 200 mg; HDM1002 tablet, oral, 200 mg single dose
Experimental: HDM1002 400 mg	Drug: HDM1002 400 mg; HDM1002 tablet, oral, 400 mg single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Categorical outliers for QTc, HR, PR, and QRS	QTc, PR, and QRS expressed as msec, HR expressed as beats per minute	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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2026
• Primary Completion (Estimated): September 25, 2026
• Study Completion (Estimated): November 6, 2026

Study Registration Dates

• First Submitted: May 6, 2026
• First Submitted That Met QC Criteria: May 17, 2026
• First Posted (Actual): May 19, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 17, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Moxifloxacin
• Other Study ID Numbers: HDM1002-110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No