A Study of HDM1002 Tablets on Cardiac Repolarization in Healthy Subjects

Официальное название

A Phase I, Single-center, Randomized, Double-blind, Placebo- and Positive-controlled, Four-period, Crossover Clinical Study to Evaluate the Effect of HDM1002 Tablets on Cardiac Repolarization in Healthy Subjects

Обзор

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.

Вмешательства

• Препарат HDM1002 200 mg
  HDM1002 tablet, oral, 200 mg single dose
• Препарат HDM1002 400 mg
  HDM1002 tablet, oral, 400 mg single dose
• Препарат Placebo
  Placebo tablet, oral, single dose
• Препарат Moxifloxacin 400 mg
  Moxifloxacin tablet, oral, 400 mg single dose

Первичные конечные точки

• Correlation between HDM1002 Plasma Concentration and ΔΔQTc [Срок оценки: From the base line ECG (Day -1) to end of the period, up to 48 hours post-dose]

Вторичные конечные точки (2)

• Categorical outliers for QTc, HR, PR, and QRS [Срок оценки: From the base line ECG (Day -1) to end of the period, up to 48 hours post-dose]
• Incidence of adverse events (AEs) and serious adverse events (SAEs) [Срок оценки: 25 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• PKUcare Luzhong Hospital — Zibo

Идентификаторы

NCT: NCT07594847 · HDM1002-110

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗