NCT07594847 A Study of HDM1002 Tablets on Cardiac Repolarization in Healthy Subjects
| NCT ID | NCT07594847 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. |
| Condition | Healthy Adult Subject |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2026-03-07 |
| Primary Completion | 2026-09-25 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 72 participants in total. It began in 2026-03-07 with a primary completion date of 2026-09-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Frequently Asked Questions
Who can join the NCT07594847 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Healthy Adult Subject. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07594847 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07594847 currently recruiting?
Yes, NCT07594847 is actively recruiting participants. Visit ClinicalTrials.gov or contact Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. to inquire about joining.
Where is the NCT07594847 trial being conducted?
This trial is being conducted at Zibo, China.
Who is sponsoring the NCT07594847 clinical trial?
NCT07594847 is sponsored by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.. The trial plans to enroll 72 participants.