NCT07594847招募中1 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Correlation between HDM1002 Plasma Concentration and ΔΔQTc
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
HDM1002 200 mg
Experimental
干预措施: HDM1002 200 mg (Drug)
HDM1002 400 mg
Experimental
干预措施: HDM1002 400 mg (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Moxifloxacin
Active Comparator
干预措施: Moxifloxacin 400 mg (Drug)
结局指标
主要结局
Correlation between HDM1002 Plasma Concentration and ΔΔQTc
时间窗: 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.
次要结局
- 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)
- Incidence of adverse events (AEs) and serious adverse events (SAEs)(25 days)
研究者
研究点 (1)
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