TNM002 Injection is a recombinant fully human native monoclonal antibody (mAb) against tetanus toxin and is currently under development for indication of prophylaxis against tetanus.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
675
Dosage Form: Injection, solution Route of administration: IM gluteal injection
Dosage Form: Injection, solution Route of administration: IM gluteal injection
Percentage of Participants With ∆Titers ≥0.01 IU/mL at 12 Hours Post-dose
The change of anti-tetanus neutralizing antibody titers from baseline 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: Baseline up to 12 hours after receipt of study drug
Tetanus Protection Rate on Day 28 Post-dose
The tetanus protection rate is defined as 1 minus the incidence of tetanus in the study population. The table presents the number of participants who remained free from clinical tetanus over the specified time frame.
Time frame: Up to 28 days after receipt of study drug
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Hefei First People's Hospital
Hefei, Anhui, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Beijing Tiantan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Guangdong Provincial Hospital of Chinese Medicine
Guangzhou, Guangdong, China
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
...and 18 more locations