A Phase 1, Single and Multiple Subcutaneous Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics of TB001 Injection in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Incidence and severity of adverse events (AEs)
研究概览
简要总结
It was a randomized, double-blind, placebo-controlled combined single ascending dose (SAD) and multiple ascending dose (MAD) study, evaluating the safety, tolerability and pharmacokinetics of TB001 after single and multiple subcutaneous injections in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written and signed informed consent.
- •Aged 18-55 years (inclusive), male or female.
- •BMI within 18.0-28.0 kg/m2 (inclusive).
- •Have physically and psychologically health judged by the investigator based on the medical history, physical examination, laboratory evaluation, electrocardiogram, etc.
- •Have agreed to take effective contraception measures.
排除标准
- •Have any prior clinically serious disease of any system.
- •Known or suspected allergy to the study drug or any of its ingredients.
- •Severe infection, severe trauma or major surgical operation within 3 months prior to the first administration.
- •History of recurrent or chronic infection within 6 months prior to the first administration.
- •Unable to comply with dietary management during the study period.
- •Pregnant or lactating women.
研究组 & 干预措施
Multiple-dose of placebo
In the MAD stage, participants will receive subcutaneous injection of placebo once daily for 7 days.
干预措施: Placebo (Drug)
Single-dose of TB001
In the SAD stage, participants will receive subcutaneous injection of TB001 once on Day 1, planning to ascend from 20 μg, 60 μg，150 μg，300 μg，600μg to 900 μg or higher dose (whether to proceed to the next higher cohort based on dose escalation criteria). Actual dose of TB001 may vary based on safety, tolerability and PK data from previous cohorts.
干预措施: TB001 (Drug)
Multiple-dose of TB001
In the MAD stage, participants will receive subcutaneous injection of TB001 once daily for 7 days, planning to ascend from 60 μg，150ug to 300 μg or higher dose (whether to proceed to the next higher cohort based on dose escalation criteria). Actual dose of TB001 may vary based on safety, tolerability and PK data from previous cohorts.
干预措施: TB001 (Drug)
Single-dose of placebo
In the SAD stage, participants will receive subcutaneous injection of placebo once on Day 1.
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence and severity of adverse events (AEs)
时间窗: Day 1 and up to Day 28
An AE is any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship.
次要结局
- Pharmacokinetics exposure of TB001 in SAD and MAD stage(Day 1 , Day 7)
- Observed immunogenicity of TB001 in MAD stage(Day 1, Day 7, Day 14, Day 28)