This study is designed as a randomized, open-label, parallel-design study to evaluate the effect of TNM002 simultaneously administered with adsorbed tetanus vaccine on the PK, PD and immunogenicity properties of TNM002 and on the PD properties of the adsorbed tetanus vaccine, and to evaluate the safety and tolerability of TNM002 administered alone and simultaneously administered with adsorbed tetanus vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
A single intramuscular (IM) gluteal injection
A single IM deltoid injection
A single IM gluteal injection+ a single IM deltoid injection
PKUCare Luzhong Hospital
Zibo, Shandong, China
Maximum concentration (Cmax) of TNM002, area under the plasma concentration-time curve from time 0 to the last quantifiable time point post-dose (AUC0-last)
Time frame: Up to Day 106
Percentage of subjects with an increase of serum TNM002-specific anti-tetanus neutralizing antibody titers (ΔTiters) ≥ 0.01 IU/mL from baseline at 24 hours after immunization
Time frame: Up to 24 hours after administration
Percentage of subjects with serum anti-tetanus antibody titers ≥ 0.1 IU/mL on 28 days after immunization
Time frame: Up to 28 days after administration
Time to maximum serum TNM002 concentration (Tmax), elimination half-life (t1/2), and if data permit, apparent clearance (CL/F) and apparent volume of distribution (Vz/F) after immunization
Time frame: Up to Day 106
Percentage of subjects with anti-tetanus neutralizing antibody ΔTiters ≥ 0.01 IU/mL at post-dose time points other than 24 hours after immunization
Time frame: Up to Day 106
Serum TNM002-specific anti-tetanus neutralizing antibody titer and ΔTiters at each post-dose time point after immunization
Time frame: Up to Day 106
Percentage of subjects with anti-tetanus antibody titer ≥ 0.1 IU/mL at post-dose time points other than 28 days after immunization
Time frame: Up to Day 106
Percentage of subjects with serum anti-tetanus antibody titer ≥ 1.0 IU/mL at each post-dose time point after immunization
Time frame: Up to Day 106
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Serum anti-tetanus antibody titers, and fold increases from baseline at each post-dose time point
Time frame: Up to Day 106
Adverse events (AEs), safety laboratory test, 12-lead electrocardiogram (ECG), physical examination, and vital signs
Time frame: Up to Day 106
Percentage of subjects with positive anti-TNM002 antibody (ADA) in serum.
Time frame: Up to Day 106