Clinical trial NCT05630573: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Respiratory Syncytial Virus Infections
Lead sponsor: Zhuhai Trinomab Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-11-29
Enrollment: 31
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

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 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.

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

Primary outcomes:
measure: Safety and tolerability of TNM001 Injection
timeFrame: 150 days post dose
Secondary outcomes:
measure: Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) of TNM001
timeFrame: 150 days post dose
measure: Maximum Observed Serum Concentration (Cmax) of TNM001
timeFrame: 150 days post dose
measure: Terminal Elimination Half Life (t1/2) of TNM001
timeFrame: 150 days post dose
measure: Serum anti-RSV neutralizing antibodies titer levels in each dose cohort
timeFrame: 150 days post dose
measure: Anti-drug antibody (ADA) positive rate of TNM001
timeFrame: 150 days post dose
Other outcomes:
measure: Lower respiratory tract infection(LRTI)
timeFrame: 150 days post dose
Locations:
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Changsha
country: China
facility: Hunan Provincial People's Hospital
state: Hunan
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Linfen
country: China
facility: Linfen People's Hospital
state: Shanxi
city: Yuncheng
country: China
facility: Yuncheng Central Hospital
state: Shanxi
city: Chengdu
country: China
facility: West China Second University Hospital, Sichuan University
state: Sichuan
Study officials:
affiliation: West China Second Hospital, Sichuan University
name: Hanmin Liu
role: PRINCIPAL_INVESTIGATOR
affiliation: West China Second Hospital, Sichuan University
name: Qin Yu
role: PRINCIPAL_INVESTIGATOR
References: