A Study of TNM001 in Chinese Healthy Preterm and Term Infants

Respiratory Syncytial Virus Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05630573
• Other study ID #: TNM001-201
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 25, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: June 2024
• Source: Zhuhai Trinomab Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 1 Year

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Syncytial Virus Infections

Intervention

Biological:
• TNM001
intramuscular injection
• Placebo
intramuscular injection

Locations

Country	Name	City	State
China	Hunan Provincial People's Hospital	Changsha	Hunan
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan
China	West China Second University Hospital, Sichuan University	Chengdu	Sichuan
China	Linfen People's Hospital	Linfen	Shanxi
China	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Yuncheng Central Hospital	Yuncheng	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Zhuhai Trinomab Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Lower respiratory tract infection(LRTI)	The incidence of LRTI	150 days post dose
Primary	Safety and tolerability of TNM001 Injection	Type and incidence of adverse events and serious adverse events	150 days post dose
Secondary	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
Secondary	Maximum Observed Serum Concentration (Cmax) of TNM001	The Cmax is the maximum observed serum concentration of TNM001	150 days post dose
Secondary	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
Secondary	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
Secondary	Anti-drug antibody (ADA) positive rate of TNM001	The evaluation indicator of immunogenicity is the ADA positive rate in subjects	150 days post dose