Health TrialsbyHealthPanel

A Study of HDM1002 Tablets on Cardiac Repolarization in Healthy Subjects

ConditionHealthy Adult Subject
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

This trial accepts healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • HDM1002 200 mg

    Drug

    HDM1002 tablet, oral, 200 mg single dose

  • HDM1002 400 mg

    Drug

    HDM1002 tablet, oral, 400 mg single dose

  • Placebo

    Drug

    Placebo tablet, oral, single dose

  • Moxifloxacin 400 mg

    Drug

    Moxifloxacin tablet, oral, 400 mg single dose

Treatment groups

72 Participants
are divided into 4 treatment groups
Group A: HDM1002 200 mgExperimental treatment 1 intervention
Group B: HDM1002 400 mgExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Group D: MoxifloxacinActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Correlation between HDM1002 Plasma Concentration and ΔΔQTc

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.

Time frame
From the base line ECG (Day -1) to end of the period, up to 48 hours post-dose

Secondary outcomes

1

Categorical outliers for QTc, HR, PR, and QRS

QTc, PR, and QRS expressed as msec, HR expressed as beats per minute

Time frame
From the base line ECG (Day -1) to end of the period, up to 48 hours post-dose
2

Incidence of adverse events (AEs) and serious adverse events (SAEs)

Time frame
25 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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