Back to resultsStudy to Compare the Anti-tetanus Neutralizing Antibody Titers and Safety of TNM002 Injection With Human Tetanus Immunoglobulin or Placebo in Adult Volunteers
Primary Purpose
Tetanus
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
TNM002 (low dose)
TNM002 (medium dose)
TNM002 (high dose)
HTIG
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Tetanus
Eligibility Criteria
Inclusion Criteria: Chinese male or female adults aged ≥ 18 years; Healthy volunteers or volunteers with stable chronic diseases; Volunteers who provide signed written informed consent form. Exclusion Criteria: History of allergy to the investigational product, human immunoglobulin preparation or any component of other therapeutic monoclonal immunoglobulins; Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation; History of alcohol or other substance abuse.
Sites / Locations
- The First Affiliated Hospital of Shantou University Medical College
- Wuxi People's Hospital
- PKUCare Luzhong Hospital
- Yunnan Provincial Hospital of Traditional Chinese Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
TNM002 low dose
TNM002 medium dose
TNM002 high dose
Human Tetanus Immunoglobulin (HTIG)
Placebo
Arm Description
Participants receive a single intramuscular injection of TNM002 with low dose on Day 1
Participants receive a single intramuscular injection of TNM002 with medium dose on Day 1
Participants receive a single intramuscular injection of TNM002 with high dose on Day 1
Participants receive a single intramuscular injection of human tetanus immunoglobulin 250 IU on Day 1
Participants receive a single intramuscular injection of placebo on Day 1
Outcomes
Primary Outcome Measures
Proportion of volunteers with an increase of anti-tetanus neutralizing antibody titers over protective level
Secondary Outcome Measures
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Change from baseline in anti-tetanus neutralizing antibody titers (∆ titers)
Proportion of volunteers with an increase of anti-tetanus neutralizing antibody titers over protective level
Duration of anti-tetanus neutralizing antibody titers increasing from baseline over protective level post-dose
Maximum concentration (Cmax) of TNM002
Time to maximum concentration (Tmax) of TNM002
Elimination half-life (T1/2) of TNM002
Area under the concentration-time curve from time 0 to t (AUC0-t) of TNM002
Area under the concentration-time curve from time 0 to ∞ (AUC0-∞) of TNM002
Positive rate of ADA in volunteers in TNM002 groups
Full Information
NCT ID
NCT05625477
First Posted
November 11, 2022
Last Updated
May 18, 2023
Sponsor
Zhuhai Trinomab Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05625477
Brief Title
Study to Compare the Anti-tetanus Neutralizing Antibody Titers and Safety of TNM002 Injection With Human Tetanus Immunoglobulin or Placebo in Adult Volunteers
Official Title
A Multicenter, Randomized, Double-Blind, Parallel-Controlled, Dose-Finding Phase II Study to Compare the Anti-tetanus Neutralizing Antibody Titers and Safety of TNM002 Injection With Human Tetanus Immunoglobulin or Placebo Following a Single Intramuscular Injection in Chinese Adult Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 18, 2022 (Actual)
Primary Completion Date
May 29, 2022 (Actual)
Study Completion Date
October 18, 2022 (Actual)
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
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective is to compare the anti-tetanus neutralizing antibody titers of TNM002 Injection with human tetanus immunoglobulin (HTIG) following a single intramuscular (IM) injection in Chinese adult volunteers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tetanus
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TNM002 low dose
Arm Type
Experimental
Arm Description
Participants receive a single intramuscular injection of TNM002 with low dose on Day 1
Arm Title
TNM002 medium dose
Arm Type
Experimental
Arm Description
Participants receive a single intramuscular injection of TNM002 with medium dose on Day 1
Arm Title
TNM002 high dose
Arm Type
Experimental
Arm Description
Participants receive a single intramuscular injection of TNM002 with high dose on Day 1
Arm Title
Human Tetanus Immunoglobulin (HTIG)
Arm Type
Active Comparator
Arm Description
Participants receive a single intramuscular injection of human tetanus immunoglobulin 250 IU on Day 1
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants receive a single intramuscular injection of placebo on Day 1
Intervention Type
Biological
Intervention Name(s)
TNM002 (low dose)
Intervention Description
Single dose of TNM002 administered by intramuscular injection
Intervention Type
Biological
Intervention Name(s)
TNM002 (medium dose)
Intervention Description
Single dose of TNM002 administered by intramuscular injection
Intervention Type
Biological
Intervention Name(s)
TNM002 (high dose)
Intervention Description
Single dose of TNM002 administered by intramuscular injection
Intervention Type
Biological
Intervention Name(s)
HTIG
Intervention Description
Single dose of HTIG administered by intramuscular injection
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Single dose of placebo administered by intramuscular injection
Primary Outcome Measure Information:
Title
Proportion of volunteers with an increase of anti-tetanus neutralizing antibody titers over protective level
Time Frame
At 24 hours post-dose
Secondary Outcome Measure Information:
Title
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time Frame
Up to 105 days post dosing
Title
Change from baseline in anti-tetanus neutralizing antibody titers (∆ titers)
Time Frame
At 24 hours, 48 hours, and on Days 3, 7, 21, 30 and 90 post-dose
Title
Proportion of volunteers with an increase of anti-tetanus neutralizing antibody titers over protective level
Time Frame
At 48 hours and on Days 3, 7, 21, 30, and 90 post-dose
Title
Duration of anti-tetanus neutralizing antibody titers increasing from baseline over protective level post-dose
Time Frame
Up to 105 days post dosing
Title
Maximum concentration (Cmax) of TNM002
Time Frame
Up to 105 days post dosing
Title
Time to maximum concentration (Tmax) of TNM002
Time Frame
Up to 105 days post dosing
Title
Elimination half-life (T1/2) of TNM002
Time Frame
Up to 105 days post dosing
Title
Area under the concentration-time curve from time 0 to t (AUC0-t) of TNM002
Time Frame
Up to 105 days post dosing
Title
Area under the concentration-time curve from time 0 to ∞ (AUC0-∞) of TNM002
Time Frame
Up to 105 days post dosing
Title
Positive rate of ADA in volunteers in TNM002 groups
Time Frame
Up to 105 days post dosing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Chinese male or female adults aged ≥ 18 years;
Healthy volunteers or volunteers with stable chronic diseases;
Volunteers who provide signed written informed consent form.
Exclusion Criteria:
History of allergy to the investigational product, human immunoglobulin preparation or any component of other therapeutic monoclonal immunoglobulins;
Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation;
History of alcohol or other substance abuse.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jie Hou
Organizational Affiliation
Peking University Care Luzhong Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Shantou University Medical College
City
Shantou
State/Province
Guangdong
Country
China
Facility Name
Wuxi People's Hospital
City
Wuxi
State/Province
Jiangsu
Country
China
Facility Name
PKUCare Luzhong Hospital
City
Zibo
State/Province
Shandong
Country
China
Facility Name
Yunnan Provincial Hospital of Traditional Chinese Medicine
City
Kunming
State/Province
Yunnan
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Study to Compare the Anti-tetanus Neutralizing Antibody Titers and Safety of TNM002 Injection With Human Tetanus Immunoglobulin or Placebo in Adult Volunteers
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