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A Study of TNM001 in Chinese Healthy Preterm and Term Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05630573
Recruitment Status : Completed
First Posted : November 29, 2022
Last Update Posted : June 21, 2024
Sponsor:
Information provided by (Responsible Party):
Zhuhai Trinomab Pharmaceutical Co., Ltd.

Study Description
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Brief Summary:

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

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus Infections Biological: TNM001 Biological: Placebo Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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
Actual Study Start Date : October 25, 2022
Actual Primary Completion Date : June 30, 2023
Actual Study Completion Date : June 30, 2023

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Safety and tolerability of TNM001 Injection [ Time Frame: 150 days post dose ]
    Type and incidence of adverse events and serious adverse events


Secondary Outcome Measures :
  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 Outcome Measures:
  1. Lower respiratory tract infection(LRTI) [ Time Frame: 150 days post dose ]
    The incidence of LRTI


Eligibility Criteria
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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05630573


Locations
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China, Hebei
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050000
China, Hunan
Hunan Provincial People's Hospital
Changsha, Hunan, China, 410005
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China, 410006
China, Shanxi
Linfen People's Hospital
Linfen, Shanxi, China, 041000
Yuncheng Central Hospital
Yuncheng, Shanxi, China, 044099
China, Sichuan
West China Second University Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Sponsors and Collaborators
Zhuhai Trinomab Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Hanmin Liu West China Second Hospital, Sichuan University
Principal Investigator: Qin Yu West China Second Hospital, Sichuan University
More Information
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Responsible Party: Zhuhai Trinomab Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT05630573    
Other Study ID Numbers: TNM001-201
First Posted: November 29, 2022    Key Record Dates
Last Update Posted: June 21, 2024
Last Verified: June 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Syncytial Virus Infections
Virus Diseases
Infections
Pneumovirus Infections
 Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections