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

Phase 2

Completed

• Conditions: Tetanus
• Interventions: Biological: TNM002 (low dose); Biological: TNM002 (high dose); Biological: HTIG; Biological: TNM002 (medium dose); Biological: Placebo

• Registration Number: NCT05625477
• Lead Sponsor: Zhuhai Trinomab Pharmaceutical Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-18
• Primary Completion: 2022-05-29
• Study Completion: 2022-10-18
• Study First Submitted: 2022-11-11
• Study First Submitted QC: 2022-11-20
• Study First Posted: 2022-11-23
• Status Verified: 2023-05
• Disposition First Submitted: 2023-05-18
• Last Update Submitted: 2023-05-18
• Disposition First Posted: 2023-05-23
• Last Update Posted: 2023-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TNM002 low dose	TNM002 (low dose)	Participants receive a single intramuscular injection of TNM002 with low dose on Day 1
TNM002 high dose	TNM002 (high dose)	Participants receive a single intramuscular injection of TNM002 with high dose on Day 1
Human Tetanus Immunoglobulin (HTIG)	HTIG	Participants receive a single intramuscular injection of human tetanus immunoglobulin 250 IU on Day 1
TNM002 medium dose	TNM002 (medium dose)	Participants receive a single intramuscular injection of TNM002 with medium dose on Day 1
Placebo	Placebo	Participants receive a single intramuscular injection of placebo on Day 1

Primary Outcome Measures

Name	Time	Method
Proportion of volunteers with an increase of anti-tetanus neutralizing antibody titers over protective level	At 24 hours post-dose

Secondary Outcome Measures

Name	Time	Method
Maximum concentration (Cmax) of TNM002	Up to 105 days post dosing
Positive rate of ADA in volunteers in TNM002 groups	Up to 105 days post dosing
Incidence of adverse events (AEs) and serious adverse events (SAEs)	Up to 105 days post dosing
Time to maximum concentration (Tmax) of TNM002	Up to 105 days post dosing
Duration of anti-tetanus neutralizing antibody titers increasing from baseline over protective level post-dose	Up to 105 days post dosing
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
Area under the concentration-time curve from time 0 to ∞ (AUC0-∞) of TNM002	Up to 105 days post dosing
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
Elimination half-life (T1/2) of TNM002	Up to 105 days post dosing
Area under the concentration-time curve from time 0 to t (AUC0-t) of TNM002	Up to 105 days post dosing

Trial Locations

Locations (4)

Wuxi People's Hospital; 🇨🇳 Wuxi, Jiangsu, China

The First Affiliated Hospital of Shantou University Medical College; 🇨🇳 Shantou, Guangdong, China

PKUCare Luzhong Hospital; 🇨🇳 Zibo, Shandong, China

Yunnan Provincial Hospital of Traditional Chinese Medicine; 🇨🇳 Kunming, Yunnan, China