A Study of TNM001 in Chinese Healthy Preterm and Term Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-25

Study Completion Date

2023-06-30

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

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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 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.

Conditions

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Respiratory Syncytial Virus Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TNM001 Injection dose 1

low dose administered

Group Type EXPERIMENTAL

TNM001

Intervention Type BIOLOGICAL

intramuscular injection

TNM001 Injection dose 2

medium dose administered

Group Type EXPERIMENTAL

TNM001

Intervention Type BIOLOGICAL

intramuscular injection

TNM001 Injection dose 3

high dose administered

Group Type EXPERIMENTAL

TNM001

Intervention Type BIOLOGICAL

intramuscular injection

placebo

placebo administered

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

intramuscular injection

Interventions

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TNM001

intramuscular injection

Intervention Type BIOLOGICAL

Placebo

intramuscular injection

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Healthy preterm infants and term infants within 1 year old of age
2. Infants who are in the first RSV infection season at the time of randomization

Exclusion Criteria

1. Any fever or acute illness within 7 days prior to dosing
2. LRTI prior to randomization
3. Received any anti-RSV monoclonal antibody or RSV vaccine
4. 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
5. The subject is a child of the investigator or his/her subordinate study personnel or relatives or sponsor staff

Maximum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes