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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
31
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
Safety and tolerability of TNM001 Injection
Type and incidence of adverse events and serious adverse events
Time frame: 150 days post dose
Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) of TNM001
The pharmacokinetic (PK) parameter AUC (0-infinity) will be estimated based on the serum concentrations of TNM001
Time frame: 150 days post dose
Maximum Observed Serum Concentration (Cmax) of TNM001
The Cmax is the maximum observed serum concentration of TNM001
Time frame: 150 days post dose
Terminal Elimination Half Life (t1/2) of TNM001
Terminal phase elimination half-life (t1/2) is the time required for half of the drug to be eliminated from the serum
Time frame: 150 days post dose
Serum anti-RSV neutralizing antibodies titer levels in each dose cohort
To summarize the proportion of subjects with severalfold increase after dosing compared to the predose (baseline)
Time frame: 150 days post dose
Anti-drug antibody (ADA) positive rate of TNM001
The evaluation indicator of immunogenicity is the ADA positive rate in subjects
Time frame: 150 days post dose
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Yuncheng Central Hospital
Yuncheng, Shanxi, China
West China Second University Hospital, Sichuan University
Chengdu, Sichuan, China