NCT06951945已完成1 期
Multiple Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of THDBH120 in Chinese Patients With Obesity: A Randomized, Bouble-Blind, Placebo-Controlled Phase Ib Trial
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Number of Participants with One or More Adverse Event(s) and Serious Adverse Event(s)
研究概览
简要总结
The aim of this trial is to investigate the safety, tolerability, pharmacokinetics, and efficacy of THDBH120 injection in participants with obesity. This study includes three multiple-ascending dose cohorts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years (inclusive), male or female;
- •Body mass index (BMI) ≥ 28 kg/m²;
- •Diet and exercise control for at least 3 months before screening visit, and less than 5% self-reported change within the last 3 months.
排除标准
- •Type 1 diabetes, type 2 diabetes, gestational diabetes, or other types of diabetes;
- •History of obesity attributable to endocrine diseases, monogenic mutations, or drug-induced causes, such as hypothalamic obesity, pituitary obesity, hypothyroid obesity, Cushing's syndrome, insulinoma, acromegaly, or hypogonadism; or weight gain resulting from increased non-fat mass (e.g., edema);
- •Presence of uncontrolled hypertension at screening: systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg;
- •Prolonged QTcF interval on 12-lead ECG at screening (QTcF≥450 ms for males, >470 ms for females), PR interval >200 ms, or the presence of long QT syndrome, second- or third-degree atrioventricular block, left or right bundle branch block, Wolff-Parkinson-White syndrome, or any other clinically significant arrhythmias (except sinus arrhythmia).
研究组 & 干预措施
THDBH120 injection
Experimental
干预措施: THDBH120 injection (Drug)
Placebo of THDBH120 injection
Placebo Comparator
干预措施: Placebo of THDBH120 injection (Drug)
结局指标
主要结局
Number of Participants with One or More Adverse Event(s) and Serious Adverse Event(s)
时间窗: 78 days
次要结局
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of THDBH120.(Day 1 Pre-dose through Day 43)
- Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of THDBH120(Day 1 Pre-dose through Day 43)
- Change From Baseline in Body Weight(43 days)
- Number of Participants With Anti-THBHD120 Antibodies(78 days)
研究者
研究点 (2)
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