HDM1002 tablets and heart rhythm in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase, interventional study will compare the effects of HDM1002 tablets at two dose levels to placebo on cardiac repolarization in healthy volunteers. A positive control with moxifloxacin is included to validate the study’s ability to detect QT changes. Participants will be randomly assigned to receive one of the three active treatments or placebo, with serial ECG measurements and safety monitoring. The trial aims to determine whether a single oral dose of HDM1002 has any clinically meaningful effect on heart rhythm in the absence of disease. The study is conducted at a single site in Zibo, Shandong, sponsored by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Why it matters

Who can join: the full rules

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.

Where it's running

• PKUcare Luzhong Hospital
  Zibo, Shangdong, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.