A Study of TNM001 in Chinese Healthy Preterm and Term Infants
- Conditions
- Respiratory Syncytial Virus Infections
- Interventions
- Biological: TNM001Biological: Placebo
- Registration Number
- NCT05630573
- Lead Sponsor
- Zhuhai Trinomab Pharmaceutical Co., Ltd.
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
- 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
Key
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description TNM001 Injection dose 2 TNM001 medium dose administered TNM001 Injection dose 1 TNM001 low dose administered TNM001 Injection dose 3 TNM001 high dose administered placebo Placebo placebo administered
- Primary Outcome Measures
Name Time Method Safety and tolerability of TNM001 Injection 150 days post dose Type and incidence of adverse events and serious adverse events
- Secondary Outcome Measures
Name Time Method Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) of TNM001 150 days post dose The pharmacokinetic (PK) parameter AUC (0-infinity) will be estimated based on the serum concentrations of TNM001
Anti-drug antibody (ADA) positive rate of TNM001 150 days post dose The evaluation indicator of immunogenicity is the ADA positive rate in subjects
Maximum Observed Serum Concentration (Cmax) of TNM001 150 days post dose The Cmax is the maximum observed serum concentration of TNM001
Serum anti-RSV neutralizing antibodies titer levels in each dose cohort 150 days post dose To summarize the proportion of subjects with severalfold increase after dosing compared to the predose (baseline)
Terminal Elimination Half Life (t1/2) of TNM001 150 days post dose Terminal phase elimination half-life (t1/2) is the time required for half of the drug to be eliminated from the serum
Related Research Topics
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Trial Locations
- Locations (6)
The Second Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Hunan Provincial People's Hospital
🇨🇳Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Linfen People's Hospital
🇨🇳Linfen, Shanxi, China
West China Second University Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China
Yuncheng Central Hospital
🇨🇳Yuncheng, Shanxi, China