Back to resultsA Study of TNM001 in Chinese Healthy Preterm and Term Infants
Primary Purpose
Respiratory Syncytial Virus Infections
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
TNM001
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Respiratory Syncytial Virus Infections
Eligibility Criteria
Key Inclusion Criteria: 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 Key Exclusion Criteria: 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
Sites / Locations
- The Second Hospital of Hebei Medical UniversityRecruiting
- Hunan Provincial People's Hospital
- The Third Xiangya Hospital of Central South University
- Linfen People's Hospital
- Yuncheng Central Hospital
- West China Second University Hospital, Sichuan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
TNM001 Injection dose 1 or placebo
TNM001 Injection dose 2 or placebo
TNM001 Injection dose 3 or placebo
Arm Description
low dose administered
medium dose administered
high dose administered
Outcomes
Primary Outcome Measures
Safety and tolerability of TNM001 Injection
Type and incidence of adverse events and serious adverse events
Secondary Outcome Measures
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
Maximum Observed Serum Concentration (Cmax) of TNM001
The Cmax is the maximum observed serum concentration of TNM001
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
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)
Anti-drug antibody (ADA) positive rate of TNM001
The evaluation indicator of immunogenicity is the ADA positive rate in subjects
Full Information
NCT ID
NCT05630573
First Posted
November 9, 2022
Last Updated
November 18, 2022
Sponsor
Zhuhai Trinomab Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05630573
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 25, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhuhai Trinomab Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus Infections
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TNM001 Injection dose 1 or placebo
Arm Type
Experimental
Arm Description
low dose administered
Arm Title
TNM001 Injection dose 2 or placebo
Arm Type
Experimental
Arm Description
medium dose administered
Arm Title
TNM001 Injection dose 3 or placebo
Arm Type
Experimental
Arm Description
high dose administered
Intervention Type
Biological
Intervention Name(s)
TNM001
Intervention Description
intramuscular injection
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
intramuscular injection
Primary Outcome Measure Information:
Title
Safety and tolerability of TNM001 Injection
Description
Type and incidence of adverse events and serious adverse events
Time Frame
150 days post dose
Secondary Outcome Measure Information:
Title
Area Under the Concentration-Time Curve From Zero to Infinity (AUC [0-infinity]) of TNM001
Description
The pharmacokinetic (PK) parameter AUC (0-infinity) will be estimated based on the serum concentrations of TNM001
Time Frame
150 days post dose
Title
Maximum Observed Serum Concentration (Cmax) of TNM001
Description
The Cmax is the maximum observed serum concentration of TNM001
Time Frame
150 days post dose
Title
Terminal Elimination Half Life (t1/2) of TNM001
Description
Terminal phase elimination half-life (t1/2) is the time required for half of the drug to be eliminated from the serum
Time Frame
150 days post dose
Title
Serum anti-RSV neutralizing antibodies titer levels in each dose cohort
Description
To summarize the proportion of subjects with severalfold increase after dosing compared to the predose (baseline)
Time Frame
150 days post dose
Title
Anti-drug antibody (ADA) positive rate of TNM001
Description
The evaluation indicator of immunogenicity is the ADA positive rate in subjects
Time Frame
150 days post dose
Other Pre-specified Outcome Measures:
Title
Lower respiratory tract infection(LRTI)
Description
The incidence of LRTI
Time Frame
150 days post dose
10. Eligibility
Sex
All
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Key Inclusion Criteria:
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
Key Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Wang
Phone
+86 0756 7263999
Email
emma.wang@trinomab.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoyan Wen
Phone
+86 0756 7263999
Email
xiaoyan.wen@trinomab.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanmin Liu
Organizational Affiliation
West China Second Hospital, Sichuan University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Qin Yu
Organizational Affiliation
West China Second Hospital, Sichuan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiqing Zhang
Phone
+86 15803210627
Email
777yyy@sina.cn
Facility Name
Hunan Provincial People's Hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410005
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shengdan Nie
Phone
+86 18673126823
Email
792139029@qq.com
First Name & Middle Initial & Last Name & Degree
Aimin Zhang
Phone
+86 13873140648
Email
Lilly610@sina.com
Facility Name
The Third Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410006
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guoping Yang
Phone
+86 13974817168
Email
ygp9880@163.com
First Name & Middle Initial & Last Name & Degree
Minghua Yang
Phone
+86 13973135843
Email
yamahua123@163.com
Facility Name
Linfen People's Hospital
City
Linfen
State/Province
Shanxi
ZIP/Postal Code
041000
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhendong Wang
Phone
+86 15835736958
Email
Lfsrmyygcp@163.com
First Name & Middle Initial & Last Name & Degree
Jiangchuan Zhu
Phone
+86 13303576606
Email
Lfsrmyygcp@163.com
Facility Name
Yuncheng Central Hospital
City
Yuncheng
State/Province
Shanxi
ZIP/Postal Code
044099
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fengli Zhao
Phone
+86 18235960066
Email
zhaoflhh@163.com
Facility Name
West China Second University Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanmin Liu
Phone
+86 18180609009
Email
Hanmin@via.163.com
First Name & Middle Initial & Last Name & Degree
Qin Yu
Phone
+86 18180603576
Email
908929936@qq.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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A Study of TNM001 in Chinese Healthy Preterm and Term Infants
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