A Study of TNM001 in Chinese Healthy Preterm and Term Infants

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: Completed
• Conditions: Respiratory Syncytial Virus Infections
• Intervention / Treatment: Biological: TNM001; Biological: Placebo

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 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
• Enrollment (Actual): 31
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • The Second Hospital of Hebei Medical University
  • Hunan
    • Changsha, Hunan, China, 410005
      • Hunan Provincial People's Hospital
    • Changsha, Hunan, China, 410006
      • The Third XIANGYA Hospital of Central South University
  • Shanxi
    • Linfen, Shanxi, China, 041000
      • Linfen People's Hospital
    • Yuncheng, Shanxi, China, 044099
      • Yuncheng Central Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Second University Hospital, Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (Child)
• Accepts Healthy Volunteers: Yes

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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Zhuhai Trinomab Pharmaceutical 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

Study Major Dates

• Study Start (Actual): October 25, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 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): June 28, 2024
• Last Update Submitted That Met QC Criteria: June 26, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Paramyxoviridae Infections; Mononegavirales Infections; Pneumovirus Infections; Respiratory Syncytial Virus Infections
• 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: Yes
• Studies a U.S. FDA-regulated device product: No