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Recruiting NCT07594847

A Study of HDM1002 Tablets on Cardiac Repolarization in Healthy Subjects

Phase I Interventional Healthy Adult Subject

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HDM1002 200 mg, HDM1002 400 mg, Placebo, Moxifloxacin 400 mg.
Who it may be relevant to
Registry conditions: Healthy Adult Subject. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug HDM1002 200 mg
    HDM1002 tablet, oral, 200 mg single dose
  • Drug HDM1002 400 mg
    HDM1002 tablet, oral, 400 mg single dose
  • Drug Placebo
    Placebo tablet, oral, single dose
  • Drug Moxifloxacin 400 mg
    Moxifloxacin tablet, oral, 400 mg single dose

Primary outcome measures

  • 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]
Secondary outcome measures (2)
  • 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]
  • Incidence of adverse events (AEs) and serious adverse events (SAEs) [Time frame: 25 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • PKUcare Luzhong Hospital — Zibo

Identifiers

NCT: NCT07594847 · HDM1002-110

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗