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

Sponsor
Trinomab Biotech Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT05625477
Collaborator
(none)
240
Enrollment
4
Locations
5
Arms
6
Actual Duration (Months)
60
Patients Per Site
10
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: TNM002 (low dose)
  • Biological: TNM002 (medium dose)
  • Biological: TNM002 (high dose)
  • Biological: HTIG
  • Biological: Placebo
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
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
Actual Study Start Date :
Apr 18, 2022
Actual Primary Completion Date :
May 29, 2022
Actual Study Completion Date :
Oct 18, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: TNM002 low dose

Participants receive a single intramuscular injection of TNM002 with low dose on Day 1

Biological: TNM002 (low dose)
Single dose of TNM002 administered by intramuscular injection
Experimental: TNM002 medium dose

Participants receive a single intramuscular injection of TNM002 with medium dose on Day 1

Biological: TNM002 (medium dose)
Single dose of TNM002 administered by intramuscular injection
Experimental: TNM002 high dose

Participants receive a single intramuscular injection of TNM002 with high dose on Day 1

Biological: TNM002 (high dose)
Single dose of TNM002 administered by intramuscular injection
Active Comparator: Human Tetanus Immunoglobulin (HTIG)

Participants receive a single intramuscular injection of human tetanus immunoglobulin 250 IU on Day 1

Biological: HTIG
Single dose of HTIG administered by intramuscular injection
Placebo Comparator: Placebo

Participants receive a single intramuscular injection of placebo on Day 1

Biological: Placebo
Single dose of placebo administered by intramuscular injection

Outcome Measures

Primary Outcome Measures

  1. Proportion of volunteers with an increase of anti-tetanus neutralizing antibody titers over protective level [At 24 hours post-dose]

Secondary Outcome Measures

  1. Incidence of adverse events (AEs) and serious adverse events (SAEs) [Up to 105 days post dosing]

  2. 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]

  3. 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]

  4. Duration of anti-tetanus neutralizing antibody titers increasing from baseline over protective level post-dose [Up to 105 days post dosing]

  5. Maximum concentration (Cmax) of TNM002 [Up to 105 days post dosing]

  6. Time to maximum concentration (Tmax) of TNM002 [Up to 105 days post dosing]

  7. Elimination half-life (T1/2) of TNM002 [Up to 105 days post dosing]

  8. Area under the concentration-time curve from time 0 to t (AUC0-t) of TNM002 [Up to 105 days post dosing]

  9. Area under the concentration-time curve from time 0 to ∞ (AUC0-∞) of TNM002 [Up to 105 days post dosing]

  10. Positive rate of ADA in volunteers in TNM002 groups [Up to 105 days post dosing]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First Affiliated Hospital of Shantou University Medical College Shantou Guangdong China
2 Wuxi People's Hospital Wuxi Jiangsu China
3 PKUCare Luzhong Hospital Zibo Shandong China
4 Yunnan Provincial Hospital of Traditional Chinese Medicine Kunming Yunnan China

Sponsors and Collaborators

  • Trinomab Biotech Co., Ltd.

Investigators

  • Principal Investigator: Jie Hou, Peking University Care Luzhong Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Trinomab Biotech Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05625477
Other Study ID Numbers:
  • TNM002-P2-CH01
First Posted:
Nov 23, 2022
Last Update Posted:
Nov 23, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Tetanus
Tetany

Study Results

No Results Posted as of Nov 23, 2022