A Study of TNM001 in Chinese Healthy Preterm and Term Infants

Study Overview
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Brief Summary
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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
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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 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.

Official Title
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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

Conditions
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Respiratory Syncytial Virus Infections

Intervention / Treatment
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* Biological: TNM001
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Maximum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TNM001 Injection dose 1 or placebo<br>low dose administered | Biological: TNM001<br>* intramuscular injection<br>Biological: Placebo<br>* intramuscular injection<br>|
| Experimental: TNM001 Injection dose 2 or placebo<br>medium dose administered | Biological: TNM001<br>* intramuscular injection<br>Biological: Placebo<br>* intramuscular injection<br>|
| Experimental: TNM001 Injection dose 3 or placebo<br>high dose administered | Biological: TNM001<br>* intramuscular injection<br>Biological: Placebo<br>* intramuscular injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of TNM001 Injection | Type and incidence of adverse events and serious adverse events | 150 days post dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 150 days post dose | 
| Maximum Observed Serum Concentration (Cmax) of TNM001 | The Cmax is the maximum observed serum concentration of TNM001 | 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 | 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) | 150 days post dose | 
| Anti-drug antibody (ADA) positive rate of TNM001 | The evaluation indicator of immunogenicity is the ADA positive rate in subjects | 150 days post dose |