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

Study Overview
=================
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.

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

Conditions
-----------------
Tetanus

Intervention / Treatment
-----------------
* Biological: TNM002 (low dose)
* Biological: TNM002 (medium dose)
* Biological: TNM002 (high dose)
* Biological: HTIG
* Biological: Placebo


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TNM002 low dose<br>Participants receive a single intramuscular injection of TNM002 with low dose on Day 1 | Biological: TNM002 (low dose)<br>* Single dose of TNM002 administered by intramuscular injection<br>|
| Experimental: TNM002 medium dose<br>Participants receive a single intramuscular injection of TNM002 with medium dose on Day 1 | Biological: TNM002 (medium dose)<br>* Single dose of TNM002 administered by intramuscular injection<br>|
| Experimental: TNM002 high dose<br>Participants receive a single intramuscular injection of TNM002 with high dose on Day 1 | Biological: TNM002 (high dose)<br>* Single dose of TNM002 administered by intramuscular injection<br>|
| Active Comparator: Human Tetanus Immunoglobulin (HTIG)<br>Participants receive a single intramuscular injection of human tetanus immunoglobulin 250 IU on Day 1 | Biological: HTIG<br>* Single dose of HTIG administered by intramuscular injection<br>|
| Placebo Comparator: Placebo<br>Participants receive a single intramuscular injection of placebo on Day 1 | Biological: Placebo<br>* Single dose of placebo administered by intramuscular injection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of volunteers with an increase of anti-tetanus neutralizing antibody titers over protective level |  | At 24 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AEs) and serious adverse events (SAEs) |  | 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 | 
| 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 | 
| Duration of anti-tetanus neutralizing antibody titers increasing from baseline over protective level post-dose |  | Up to 105 days post dosing | 
| Maximum concentration (Cmax) of TNM002 |  | Up to 105 days post dosing | 
| Time to maximum concentration (Tmax) of TNM002 |  | Up to 105 days post dosing | 
| 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 | 
| Area under the concentration-time curve from time 0 to ∞ (AUC0-∞) of TNM002 |  | Up to 105 days post dosing | 
| Positive rate of ADA in volunteers in TNM002 groups |  | Up to 105 days post dosing |