New Drug's heart safety checked in healthy volunteers
NCT ID NCT07594847
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study checks whether a single dose of HDM1002 tablets changes the heart's electrical activity (QT interval) in 72 healthy adults aged 18-45. Participants receive the drug, a placebo, and a positive control in random order across four sessions. The goal is to see if the drug is safe for the heart, not to treat any disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 72 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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PKUcare Luzhong Hospital
RECRUITINGZibo, Shangdong, 255400, China
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