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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
240
Single dose of TNM002 administered by intramuscular injection
Single dose of TNM002 administered by intramuscular injection
Single dose of TNM002 administered by intramuscular injection
The First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, China
Wuxi People's Hospital
Wuxi, Jiangsu, China
PKUCare Luzhong Hospital
Zibo, Shandong, China
Yunnan Provincial Hospital of Traditional Chinese Medicine
Kunming, Yunnan, China
Proportion of Volunteers With an Increase of Anti-tetanus Neutralizing Antibody Titers Over Protective Level
The increase of anti-tetanus neutralizing antibody titers were defined as ΔTiters, calculated as the post-administration antibody titers minus the baseline antibody titers. The antibody protective level is ΔTiters \>0.01 IU/mL.
Time frame: At 24 hours post-dose
Change From Baseline in Anti-tetanus Neutralizing Antibody Titers (∆Titers)
The increase of anti-tetanus neutralizing antibody titers were defined as ΔTiters, calculated as the post-administration antibody titers minus the baseline antibody titers. The antibody protective level is ΔTiters \>0.01 IU/mL. The number of participants with evaluable anti-tetanus neutralizing antibody data were provided at each post-dose timepoint.
Time frame: 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
The increase of anti-tetanus neutralizing antibody titers were defined as ΔTiters, calculated as the post-administration antibody titers minus the baseline antibody titers. The antibody protective level is ΔTiters \>0.01 IU/mL. The number of participants with evaluable anti-tetanus neutralizing antibody data were provided at each post-dose timepoint.
Time frame: 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
The increase of anti-tetanus neutralizing antibody titers were defined as ΔTiters, calculated as the post-administration antibody titers minus the baseline antibody titers. The antibody protective level is ΔTiters \>0.01 IU/mL. The number of participants with evaluable anti-tetanus neutralizing antibody data were provided at each post-dose timepoint.
Time frame: Up to 105 (±7) days post dosing
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Single dose of HTIG administered by intramuscular injection
Single dose of placebo administered by intramuscular injection
Maximum Concentration (Cmax) of TNM002
The peak serum concentration of TNM002 observed after administration.
Time frame: Up to 105 days post dosing
Time to Maximum Concentration (Tmax) of TNM002
The time point at which the Cmax is observed following TNM002 administration.
Time frame: Up to 105 days post dosing
Elimination Half-life (t1/2) of TNM002
The time required for the serum concentration of TNM002 to decrease by 50% during the elimination phase.
Time frame: Up to 105 days post dosing
Area Under the Concentration-time Curve From Time 0 to t (AUC0-t) of TNM002
The total drug exposure of TNM002 over a defined time period (from administration to the last measurable concentration), calculated as the integral of the serum concentration-time curve.
Time frame: Up to 105 days post dosing
Area Under the Concentration-time Curve From Time 0 to ∞ (AUC0-∞) of TNM002
The total systemic exposure of TNM002 from administration until complete elimination, calculated by combining AUC0-t and the extrapolated area from the last measurable concentration to infinity.
Time frame: Up to 105 days post dosing
Positive Rate of ADA in Volunteers in TNM002 Groups
The proportion of participants who developed anti-drug antibodies (ADA) against TNM002 during the course of the trial.
Time frame: Up to 105 days post dosing