A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase Ib/IIa Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profile of TNM001 Injection in Chinese Healthy Preterm and Term Infants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 6
- 主要终点
- Safety and tolerability of TNM001 Injection
研究概览
简要总结
The purpose of this clinical trial is to evaluate the safety, tolerability and pharmacokinetics (PK) profile of TNM001 injection in healthy preterm and term infants. The main questions it aims to answer are:
- the safety and tolerability of TNM001 injection
- the pharmacokinetic (PK) profile of TNM001
详细描述
This phase Ib/IIa study is designed to assess the safety, tolerability, and pharmacokinetics (PK) profile TNM001 in healthy preterm and term infants. This study will also compare the incidence of Respiratory Syncytial Virus（RSV） infection between different doses of TNM001 and placebo, which will be used to select the dose to be studied in the later phase of clinical trials of TNM001. Approximately 30 subjects will be randomized and will be dosed once on Day 1 and followed up until Day 151. Around 6 investigational study centres participate in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy preterm infants and term infants within 1 year old of age
- •Infants who are in the first RSV infection season at the time of randomization
排除标准
- •Any fever or acute illness within 7 days prior to dosing
- •LRTI prior to randomization
- •Received any anti-RSV monoclonal antibody or RSV vaccine
- •Any other circumstances that, in the opinion of the investigator, may interfere with the assessment of the study drug or the interpretation of the study results
- •The subject is a child of the investigator or his/her subordinate study personnel or relatives or sponsor staff
结局指标
主要结局
Safety and tolerability of TNM001 Injection
时间窗: 150 days post dose
Type and incidence of adverse events and serious adverse events
次要结局
- Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) of TNM001(150 days post dose)
- Anti-drug antibody (ADA) positive rate of TNM001(150 days post dose)
- Maximum Observed Serum Concentration (Cmax) of TNM001(150 days post dose)
- Serum anti-RSV neutralizing antibodies titer levels in each dose cohort(150 days post dose)
- Terminal Elimination Half Life (t1/2) of TNM001(150 days post dose)