Study to Compare the Anti-tetanus Neutralizing Antibody Titers and Safety of TNM002 Injection With Human Tetanus Immunoglobulin or Placebo in Adult Volunteers

Tetanus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05625477
• Other study ID #: TNM002-P2-CH01
• Status: Completed
• Phase: Phase 2
• Start date: April 18, 2022
• Est. completion date: October 18, 2022

Study information

• Verified date: May 2023
• Source: Trinomab Biotech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: October 18, 2022
• Est. primary completion date: May 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Chinese male or female adults aged = 18 years;

2. Healthy volunteers or volunteers with stable chronic diseases;

3. Volunteers who provide signed written informed consent form.

Exclusion Criteria:

1. History of allergy to the investigational product, human immunoglobulin preparation or any component of other therapeutic monoclonal immunoglobulins;

2. Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation;

3. History of alcohol or other substance abuse.

Related Conditions & MeSH terms

• Tetanus

Intervention

Biological:
• TNM002 (low dose)
Single dose of TNM002 administered by intramuscular injection
• TNM002 (medium dose)
Single dose of TNM002 administered by intramuscular injection
• TNM002 (high dose)
Single dose of TNM002 administered by intramuscular injection
• HTIG
Single dose of HTIG administered by intramuscular injection
• Placebo
Single dose of placebo administered by intramuscular injection

Locations

Country	Name	City	State
China	Yunnan Provincial Hospital of Traditional Chinese Medicine	Kunming	Yunnan
China	The First Affiliated Hospital of Shantou University Medical College	Shantou	Guangdong
China	Wuxi People's Hospital	Wuxi	Jiangsu
China	PKUCare Luzhong Hospital	Zibo	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Trinomab Biotech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of volunteers with an increase of anti-tetanus neutralizing antibody titers over protective level		At 24 hours post-dose
Secondary	Incidence of adverse events (AEs) and serious adverse events (SAEs)		Up to 105 days post dosing
Secondary	Change from baseline in anti-tetanus neutralizing antibody titers (? titers)		At 24 hours, 48 hours, and on Days 3, 7, 21, 30 and 90 post-dose
Secondary	Proportion of volunteers with an increase of anti-tetanus neutralizing antibody titers over protective level		At 48 hours and on Days 3, 7, 21, 30, and 90 post-dose
Secondary	Duration of anti-tetanus neutralizing antibody titers increasing from baseline over protective level post-dose		Up to 105 days post dosing
Secondary	Maximum concentration (Cmax) of TNM002		Up to 105 days post dosing
Secondary	Time to maximum concentration (Tmax) of TNM002		Up to 105 days post dosing
Secondary	Elimination half-life (T1/2) of TNM002		Up to 105 days post dosing
Secondary	Area under the concentration-time curve from time 0 to t (AUC0-t) of TNM002		Up to 105 days post dosing
Secondary	Area under the concentration-time curve from time 0 to 8 (AUC0-8) of TNM002		Up to 105 days post dosing
Secondary	Positive rate of ADA in volunteers in TNM002 groups		Up to 105 days post dosing