A Study of TNM001 in Chinese Healthy Preterm and Term Infants
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
1 other identifier
interventional
31
1 country
6
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Oct 2022
Shorter than P25 for phase_1
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 25, 2022
CompletedFirst Submitted
Initial submission to the registry
November 9, 2022
CompletedFirst Posted
Study publicly available on registry
November 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedJune 28, 2024
June 1, 2024
8 months
November 9, 2022
June 26, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and tolerability of TNM001 Injection
Type and incidence of adverse events and serious adverse events
150 days post dose
Secondary Outcomes (5)
Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) of TNM001
150 days post dose
Maximum Observed Serum Concentration (Cmax) of TNM001
150 days post dose
Terminal Elimination Half Life (t1/2) of TNM001
150 days post dose
Serum anti-RSV neutralizing antibodies titer levels in each dose cohort
150 days post dose
Anti-drug antibody (ADA) positive rate of TNM001
150 days post dose
Other Outcomes (1)
Lower respiratory tract infection(LRTI)
150 days post dose
Study Arms (4)
TNM001 Injection dose 1
EXPERIMENTALlow dose administered
TNM001 Injection dose 2
EXPERIMENTALmedium dose administered
TNM001 Injection dose 3
EXPERIMENTALhigh dose administered
placebo
PLACEBO COMPARATORplacebo administered
Interventions
Eligibility Criteria
You may qualify if:
- Healthy preterm infants and term infants within 1 year old of age
- Infants who are in the first RSV infection season at the time of randomization
You may not qualify if:
- Any fever or acute illness within 7 days prior to dosing
- LRTI prior to randomization
- Received any anti-RSV monoclonal antibody or RSV vaccine
- 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
- The subject is a child of the investigator or his/her subordinate study personnel or relatives or sponsor staff
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000, China
Hunan Provincial People's Hospital
Changsha, Hunan, 410005, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410006, China
Linfen People's Hospital
Linfen, Shanxi, 041000, China
Yuncheng Central Hospital
Yuncheng, Shanxi, 044099, China
West China Second University Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hanmin Liu
West China Second Hospital, Sichuan University
- PRINCIPAL INVESTIGATOR
Qin Yu
West China Second Hospital, Sichuan University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2022
First Posted
November 29, 2022
Study Start
October 25, 2022
Primary Completion
June 30, 2023
Study Completion
June 30, 2023
Last Updated
June 28, 2024
Record last verified: 2024-06