Healthy Adult Subject
Conditions
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.
Interventions
DRUGHDM1002 200 mg
HDM1002 tablet, oral, 200 mg single dose
DRUGHDM1002 400 mg
HDM1002 tablet, oral, 400 mg single dose
DRUGPlacebo
Placebo tablet, oral, single dose
DRUGMoxifloxacin 400 mg
Moxifloxacin tablet, oral, 400 mg single dose
Sponsors
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between HDM1002 Plasma Concentration and ΔΔQTc | From the base line ECG (Day -1) to end of the period, up to 48 hours post-dose | HDM1002 plasma concentration in ng/mL measured by validated LC-MS/MS; ΔΔQTc in msec derived from Fridericia-corrected QT interval with baseline and placebo correction, using 12-lead ECG read centrally in a blinded manner. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Categorical outliers for QTc, HR, PR, and QRS | From the base line ECG (Day -1) to end of the period, up to 48 hours post-dose | QTc, PR, and QRS expressed as msec, HR expressed as beats per minute |
| Incidence of adverse events (AEs) and serious adverse events (SAEs) | 25 days | — |
Countries
China
Outcome results
None listed