NCT06744868已完成1 期
A Single- and Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of THDBH120 Injection in Healthy Subjects: A Randomized, Bouble-Blind, Placebo-Controlled Phase I Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 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
This study includes single-ascending dose cohorts (SAD cohorts) and multiple-ascending dose cohorts (MAD cohorts). The aim of this trial is to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of THDBH120 injection in healthy patients.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Chinese subjects aged 18 to 45 years (inclusive), male or female;
- •Body Mass Index (BMI) ≥ 19 kg/m2 and ≤ 28kg/m2, male weight ≥ 50 kg, females weight≥ 45 kg;
- •Normal or abnormal but not clinically significant physical examination and vital signs at screening.
排除标准
- •Have a diagnosis of type 2 diabetes or have had episode of severe hypoglycemia;
- •Pulse rate is less than 50 bpm or more than 100 bpm at screening;
- •12-lead electrocardiogram with prolonged QTcF (male >450 ms, female >470 ms) or PR>200ms. Or any other situation in which a 12-lead ECG suggests a risk of ineligibility at screening;
- •A history of pancreatitis (including chronic pancreatitis or idiopathic acute pancreatitis), abnormal amylase and lipase with clinical significance or gastrointestinal injury (e.g., chronic gastritis, peptic ulcer, recurrent gastroesophageal reflux disease, cholecystitis, and gallstones) or any gastrointestinal disease that interferes with gastric emptying (e.g., gastric bypass surgery, pyloric stenosis);
- •Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2;
- •Use of SGLT inhibitors, DPP4 inhibitors, GLP-1 analogs, GLP-1 receptor agonists, and other drugs that investigators recognize may affect the study during the 3 months prior to randomization;
- •Have had a significant change in weight during the 6 months prior to screening, such as weight loss > 10%, or recent significant changes in diet or exercise habits.
研究组 & 干预措施
THDBH120 injection (SAD)
Experimental
干预措施: THDBH120 injection (SAD) (Drug)
Placebo of THDBH120 injection (SAD)
Placebo Comparator
干预措施: Placebo of THDBH120 injection (SAD) (Drug)
THDBH120 injection (MAD)
Experimental
干预措施: THDBH120 injection (MAD) (Drug)
Placebo of THDBH120 injection (MAD)
Placebo Comparator
干预措施: Placebo of THDBH120 injection (MAD) (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: From the first drug administration to the follow-up visit (57 days after the last drug administration)
次要结局
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of THDBH120.(Day 1 Pre-dose through Day 42 (SAD), Day 1 Pre-dose through Day 29 (MAD))
- Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of THDBH120(Day 1 Pre-dose through Day 42 (SAD), Day 1 Pre-dose through Day 29 (MAD))
- Evaluate the Fasting Blood Glucose (FBG ) of THDBH120(Day 1 Pre-dose through Day 8 (SAD), Day 1 Pre-dose through Day 29 (MAD))
- Number of Participants With Anti-THBHD120 Antibodies(From the first drug administration to the follow-up visit (57 days after the last drug administration))
研究者
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