Skip to main content
OpenTrials
Completed

NCT Number: NCT05630573

A Study of TNM001 in Chinese Healthy Preterm and Term Infants

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Respiratory Syncytial Virus Infections Infections Mononegavirales Infections Paramyxoviridae Infections Pneumovirus Infections RNA Virus Infections Virus Diseases

Age range

Up to 1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TNM001

Biological

intramuscular injection

Placebo

Biological

intramuscular injection

Primary outcomes

  1. Safety and tolerability of TNM001 Injection

    Time frame: 150 days post dose

    Type and incidence of adverse events and serious adverse events

Secondary outcomes

  1. Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) of TNM001

    Time frame: 150 days post dose

    The pharmacokinetic (PK) parameter AUC (0-infinity) will be estimated based on the serum concentrations of TNM001

  2. Maximum Observed Serum Concentration (Cmax) of TNM001

    Time frame: 150 days post dose

    The Cmax is the maximum observed serum concentration of TNM001

  3. Terminal Elimination Half Life (t1/2) of TNM001

    Time frame: 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

  4. Serum anti-RSV neutralizing antibodies titer levels in each dose cohort

    Time frame: 150 days post dose

    To summarize the proportion of subjects with severalfold increase after dosing compared to the predose (baseline)

  5. Anti-drug antibody (ADA) positive rate of TNM001

    Time frame: 150 days post dose

    The evaluation indicator of immunogenicity is the ADA positive rate in subjects

Other outcomes

  1. Lower respiratory tract infection(LRTI)

    Time frame: 150 days post dose

    The incidence of LRTI

Sponsors and collaborators

Lead sponsor

Zhuhai Trinomab Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 29, 2022
Registry last updated
Jun 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.