A Phase 1, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics of TQA3038 Injection in Healthy Adult Subjects.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Incidence of adverse events (AEs) and serious adverse events (SAEs)
研究概览
简要总结
This is a phase 1 study in which healthy adult subjects will receive TQA3038 or placebo and will be assessed for safety, tolerability, pharmacokinetics.
In the single ascending dose (SAD) part, healthy adult subjects will receive one dose of TQA3038 or placebo, administered subcutaneously (SC).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female age 18～60 years.
- •Body mass index (BMI) 19 - 26 kg/m^2.
排除标准
- •Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation；
- •History or evidence of drug or alcohol abuse；
- •History of intolerance to SC injection；
研究组 & 干预措施
TQA3038 injection
One dose of TQA3038 injection in Day 1.
干预措施: TQA3038 injection (Drug)
TQA3038 injection matching placebo
One dose of TQA3038 injection matching placebo in Day 1.
干预措施: TQA3038 injection matching placebo (Drug)
结局指标
主要结局
Incidence of adverse events (AEs) and serious adverse events (SAEs)
时间窗: Up to 85 days.
Number of subjects with adverse events (AEs) and serious adverse events (SAEs) assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Number of subjects with clinically significant abnormalities
时间窗: Up to 85 days.
Number of subjects with clinically significant abnormalities in vital signs, electrocardiogram (ECG), and laboratory parameters graded by CTCAE v5.0.
次要结局
- Maximum Plasma Concentration (Cmax)(Predose on Day 1 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, 24, 48 hours postdose)
- Area Under the Plasma Concentration Versus Time Curve (AUC)(Predose on Day 1 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, 24, 48 hours postdose)
- Apparent Terminal Elimination Half-life (T1/2)(Predose on Day 1 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, 24, 48 hours postdose)
- Time to Reach Maximum Plasma Concentration (Tmax)(Predose on Day 1 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, 24, 48 hours postdose)
- Apparent Plasma Clearance (CL/F)(Predose on Day 1 and 30 minutes, 1, 2, 4, 6, 8, 10, 12, 24, 48 hours postdose)
- Fraction eliminated in the urine(Predose, 0-4 hours, 4-8 hours, 8-12 hours, 12-24 hours, 48 hours and 168 hours after dose on Day 1.)