A Study of TNM001 in Chinese Healthy Preterm and Term Infants

November 18, 2022 updated by: Trinomab Biotech Co., Ltd.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 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

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • Recruiting
        • The Second Hospital of Hebei Medical University
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410005
        • Not yet recruiting
        • Hunan Provincial People's Hospital
        • Contact:
        • Contact:
      • Changsha, Hunan, China, 410006
        • Not yet recruiting
        • The Third Xiangya Hospital of Central South University
        • Contact:
        • Contact:
    • Shanxi
      • Linfen, Shanxi, China, 041000
        • Not yet recruiting
        • Linfen People's Hospital
        • Contact:
        • Contact:
      • Yuncheng, Shanxi, China, 044099
        • Not yet recruiting
        • Yuncheng Central Hospital
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Second University Hospital, Sichuan University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 4 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key 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

Key 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability of TNM001 Injection
Time Frame: 150 days post dose
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
Time Frame: 150 days post dose
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
Time Frame: 150 days post dose
The Cmax is the maximum observed serum concentration of TNM001
150 days post dose
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
150 days post dose
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)
150 days post dose
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
150 days post dose

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lower respiratory tract infection(LRTI)
Time Frame: 150 days post dose
The incidence of LRTI
150 days post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trinomab Biotech Co., Ltd.

Investigators

  • Principal Investigator: Hanmin Liu, West China Second Hospital, Sichuan University
  • Principal Investigator: Qin Yu, West China Second Hospital, Sichuan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

November 9, 2022

First Submitted That Met QC Criteria

November 18, 2022

First Posted (Actual)

November 29, 2022

Study Record Updates

Last Update Posted (Actual)

November 29, 2022

Last Update Submitted That Met QC Criteria

November 18, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TNM001-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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