NCT07257627已完成1 期
An Open-Label, Randomized, Three-Period Crossover Study Comparing the Pharmacokinetics and Pharmacodynamics of Single-Dose THDB0206 Injection at Different Injection Sites in Healthy Chinese Adults
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- AUCLisp(0-inf)
研究概览
简要总结
This open-label, randomized, three-period crossover, 8-hour hyperinsulinemic-euglycemic clamp study will compare the pharmacokinetic and pharmacodynamic profiles of THDB0206 after single subcutaneous administration at different injection sites in healthy Chinese adults.
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
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged ≥18 and ≤40 years at screening.
- •Body mass index (BMI) ≥18 kg/m² and <25 kg/m² at screening; body weight ≥50 kg for males and ≥45 kg for females at screening.
- •At screening, 75 g oral glucose tolerance test (OGTT): fasting venous plasma glucose <6.1 mmol/L and 2-hour post-load venous plasma glucose <7.8 mmol/L.
- •Glycated hemoglobin (HbA1c) ≤6.1% at screening.
排除标准
- •Known or suspected hypersensitivity to the investigational product or related products, or a history of severe allergies to drugs or foods.
- •Insulin release test at screening considered abnormal with clinical significance in the investigator's judgment.
- •Increased risk of thromboembolism, such as known coagulation disorders, (family) history of thrombosis, or relevant arrhythmias (e.g., paroxysmal atrial fibrillation).
- •In the investigator's judgment, a history of alcohol dependence or drug/chemical substance abuse; or positive results on drug screening/breath alcohol testing at screening; or alcohol consumption exceeding 21 units per week (male subjects) or 14 units per week (female subjects).
- •Subjects who smoked on average more than 5 cigarettes per day within 1 year prior to screening and are unwilling to abstain from smoking during the study.
- •Donation of blood or plasma within the past month, or donation of more than 300 mL of blood within 3 months prior to screening.
研究组 & 干预措施
THDB0206 injection-Upper Arm
Experimental
干预措施: THDB0206 injection-Upper arm (Drug)
THDB0206 injection-Abdomen
Experimental
干预措施: THDB0206 Injection-Abdomen (Drug)
THDB0206 injection-Thigh
Experimental
干预措施: THDB0206 Injection-Thigh (Drug)
结局指标
主要结局
AUCLisp(0-inf)
时间窗: From 0 to 8 hours
Area under the insulin lispro plasma concentration-time curve from zero to infinity
次要结局
- Cmax (Lisp)(From 0 to 8 hours)
- AUCLisp(From 0 to 8 hours)
- tmax(Lisp)(From 0 to 8 hours)
- t1/2(From 0 to 8 hours)
- CL/F(From 0 to 8 hours)
- Vz/F(From 0 to 8 hours)
- AUCGIR(From 0 to 8 hours)
- GIRtot(From 0 to 8 hours)
- GIRmax(From 0 to 8 hours)
- tGIRmax(From 0 to 8 hours)
- Number of participants with abnormal clinical laboratory findings (haematology, biochemistry and urinalysis)(From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration))
- Number of participants with abnormal 12-lead ECG parameters (PR, QR, QRS intervals and QTc)(From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration))
- Number of participants with abnormal vital signs (body temperature, supine blood pressure and pulse rate)(From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration))
- Number of participants with abnormal physical examination (general condition, head and five sense organs, neck, chest, abdomen, spine and limbs, nervous system)(From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration))
- Number of participants with hypoglycemia events in each treatment arm(From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration))
- Number of participants with injection site reactions (spontaneous pain, tenderness, itching, redness, edema, induration/infiltration, and others)(From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration))
- Number of participants with AE and SAE(From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration))
研究者
研究点 (1)
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