A Study of TNM001 in Chinese Healthy Preterm and Term Infants

• ClinicalTrials.gov Identifier: NCT05630573
• Recruitment Status: Completed
• First Posted: November 29, 2022
• Last Update Posted: June 21, 2024
• Sponsor: Zhuhai Trinomab Pharmaceutical Co., Ltd.
• Information provided by (Responsible Party): Zhuhai Trinomab Pharmaceutical Co., Ltd.

Tracking Information

• First Submitted Date: November 9, 2022
• First Posted Date: November 29, 2022
• Last Update Posted Date: June 21, 2024
• Actual Study Start Date: October 25, 2022
• Actual Primary Completion Date: June 30, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 18, 2022)

Safety and tolerability of TNM001 Injection [ Time Frame: 150 days post dose ]

Type and incidence of adverse events and serious adverse events

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 18, 2022)

• 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
• Maximum Observed Serum Concentration (Cmax) of TNM001 [ Time Frame: 150 days post dose ]
  The Cmax is the maximum observed serum concentration of TNM001
• 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
• 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)
• 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

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: November 18, 2022)

Lower respiratory tract infection(LRTI) [ Time Frame: 150 days post dose ]

The incidence of LRTI

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: A Study of TNM001 in Chinese Healthy Preterm and Term Infants
• 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

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

• 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
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Sequential Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Respiratory Syncytial Virus Infections

Intervention

• Biological: TNM001
  intramuscular injection
• Biological: Placebo
  intramuscular injection

Study Arms

• Experimental: TNM001 Injection dose 1 or placebo
  low dose administered
  Interventions:

  • Biological: TNM001
  • Biological: Placebo
• Experimental: TNM001 Injection dose 2 or placebo
  medium dose administered
  Interventions:

  • Biological: TNM001
  • Biological: Placebo
• Experimental: TNM001 Injection dose 3 or placebo
  high dose administered
  Interventions:

  • Biological: TNM001
  • Biological: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 19, 2024): 31
• Original Estimated Enrollment (submitted: November 18, 2022): 30
• Actual Study Completion Date: June 30, 2023
• Actual Primary Completion Date: June 30, 2023 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 1 Year (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT05630573
• Other Study ID Numbers: TNM001-201
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Zhuhai Trinomab Pharmaceutical Co., Ltd.
• Original Responsible Party: Same as current
• Current Study Sponsor: Zhuhai Trinomab Pharmaceutical Co., Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Zhuhai Trinomab Pharmaceutical Co., Ltd.
• Verification Date: June 2024