A Study of TNM001 in Chinese Healthy Preterm and Term Infants

• Sponsor: Trinomab Biotech Co., Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05630573
• Collaborator: (none)
• Enrollment: 30
• Locations: 6
• Arms: 3
• Anticipated Duration (Months): 14.2
• Patients Per Site: 5
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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

• Study Type: Interventional
• Anticipated Enrollment: 30 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: Oct 25, 2022
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

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

Primary Outcome Measures

1. Safety and tolerability of TNM001 Injection [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 [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 [150 days post dose]

   The Cmax is the maximum observed serum concentration of TNM001

3. Terminal Elimination Half Life (t1/2) of TNM001 [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 [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 [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) [150 days post dose]

   The incidence of LRTI

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 1 Year
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei	China	050000
2	Hunan Provincial People's Hospital	Changsha	Hunan	China	410005
3	The Third Xiangya Hospital of Central South University	Changsha	Hunan	China	410006
4	Linfen People's Hospital	Linfen	Shanxi	China	041000
5	Yuncheng Central Hospital	Yuncheng	Shanxi	China	044099
6	West China Second University Hospital, Sichuan University	Chengdu	Sichuan	China	610041

Sponsors and Collaborators

• 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Trinomab Biotech Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05630573
• Other Study ID Numbers: TNM001-201
• First Posted: Nov 29, 2022
• Last Update Posted: Nov 29, 2022
• Last Verified: Nov 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Respiratory Syncytial Virus Infections

Study Results

No Results Posted as of Nov 29, 2022