A Study of HDM1002 Tablets on Cardiac Repolarization in Healthy Subjects

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorHangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

About this trial

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

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • HDM1002 200 mg
  • HDM1002 400 mg
  • Placebo
  • Moxifloxacin 400 mg

Treatment groups

72 Participants
are divided into 4 treatment groups