A Randomized, Double-blind, Controlled, Dose-escalation Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Intramuscular Injection of Recombinant Human Anti-tetanus toxin Monoclonal Antibody Injection in Healthy Participants.
The primary objective of the study : evaluate the safety and tolerability of a single intramuscular injection of recombinant human anti-tetanus toxin monoclonal antibody injection in healthy adult participants. The secondary objectives are: 1. to evaluate the pharmacokinetic (PK) characteristics of a single intramuscular injection of recombinant human anti-tetanus toxin monoclonal antibody injection in healthy adult participants; 2. to evaluate the pharmacodynamic (PD) characteristics of a single intramuscular injection of recombinant human anti-tetanus toxin monoclonal antibody injection in healthy adult participants; 3. to evaluate the immunogenicity of a single intramuscular injection of recombinant human anti-tetanus toxin monoclonal antibody injection in healthy adult participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
68
Lanzhou Institute of Biological Products Co., Ltd.
Lanzhou, Gansu, China
The occurrence of adverse events (AEs)/serious adverse events (SAEs) (including injection site reactions) from administration to the last visit
Types of Adverse Events / Serious Adverse Reactions
Time frame: 105 days
The occurrence of adverse events (AEs)/serious adverse events (SAEs) (including injection site reactions) from administration to the last visit
Incidence of Adverse Events/Serious Adverse Reactions
Time frame: 105Days
The occurrence of adverse events (AEs)/serious adverse events (SAEs) (including injection site reactions) from administration to the last visit
Severity of Adverse Events (AEs)/Serious Adverse Reactions (SARs)
Time frame: 105Days
The occurrence of adverse events (AEs)/serious adverse events (SAEs) (including injection site reactions) from administration to the last visit
Relationship of Adverse Events (AEs)/Serious Adverse Reactions (SARs) to the Investigational Product
Time frame: 105Days
The clinical significance of changes in observation indicators at different time points after drug injection compared to pre-administration.
12-lead electrocardiogram examination:P Wave
Time frame: 105Days
The clinical significance of changes in observation indicators at different time points after drug injection compared to pre-administration.
12-lead electrocardiogram examination:QRS Complex
Time frame: 105Days
The clinical significance of changes in observation indicators at different time points after drug injection compared to pre-administration.
12-lead electrocardiogram examination:T Wave
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Time frame: 105Days
The clinical significance of changes in observation indicators at different time points after drug injection compared to pre-administration.
12-lead electrocardiogram examination:U Wave
Time frame: 105Days
The clinical significance of changes in observation indicators at different time points after drug injection compared to pre-administration.
12-lead electrocardiogram examination:PR Interval
Time frame: 105Days
The clinical significance of changes in observation indicators at different time points after drug injection compared to pre-administration.
12-lead electrocardiogram examination:QT Interval
Time frame: 105Days
The clinical significance of changes in observation indicators at different time points after drug injection compared to pre-administration.
12-lead electrocardiogram examination:ST Segment
Time frame: 105Days
Clinically significant changes in laboratory parameters from baseline at specified timepoints post-dosing
Complete Blood Count (CBC)
Time frame: 105Days
Pharmacokinetic Endpoints
Cmax: Maximum plasma concentration
Time frame: 105Days
Pharmacokinetic Endpoints
AUC\~0-t: Area under the curve from 0 to last measurable timepoint
Time frame: 105Days
Pharmacokinetic Endpoints
AUC\~0-∞: Area under the curve extrapolated to infinity
Time frame: 105Days
Pharmacokinetic Endpoints
T\~max: Time to reach Cmax
Time frame: 105Days
Pharmacokinetic Endpoints
t\~1/2: Elimination half-life
Time frame: 105Days
Pharmacokinetic Endpoints
CL/F: Apparent clearance
Time frame: 105Days
Pharmacokinetic Endpoints
Vz/F:Apparent Volume of Distribution during Terminal Phase
Time frame: 105Days
Pharmacokinetic Endpoints
MRT:Mean Residence Time
Time frame: 105Days
Pharmacodynamic Endpoints
Change in tetanus-neutralizing antibody titer from baseline within 12 hours post-dose across treatment groups
Time frame: 0 to 12 hours
Pharmacodynamic Endpoints
Percentage of participants with anti-tetanus toxin neutralizing antibody titers ≥0.01 IU/mL and ≥0.1 IU/mL at each timepoint post-dose across treatment groups
Time frame: 105Days
Pharmacodynamic Endpoints
Percentage of participants with anti-tetanus toxin neutralizing antibody titer increases from baseline ≥0.01 IU/mL and ≥0.1 IU/mL at each timepoint post-dose across treatment groups
Time frame: 105Days
Exposure-Response Analysis, E-R Analysis
Exposure-response (E-R) analysis of serum drug concentrations versus anti-tetanus toxin neutralizing antibody titers at each post-dose timepoint across treatment groups
Time frame: 105Days
Immunogenicity Endpoints
Anti-drug antibody (ADA) titers against the investigational drug (recombinant human anti-tetanus toxin monoclonal antibody) in serum at each post-dose timepoint across treatment groups
Time frame: 105Days
Immunogenicity Endpoints
Incidence of anti-drug antibodies (ADA) against the investigational drug (recombinant human anti-tetanus toxin monoclonal antibody) in serum post-dose across treatment groups
Time frame: 105Days
Immunogenicity Endpoints
In participants who tested positive for anti-drug antibodies (ADA), the incidence of neutralizing antibodies (NAb) was assessed.
Time frame: 105Days