The purpose of this clinical trial is to evaluate the safety and tolerability of TNM005 following a single dose by intramuscular (IM) administration in healthy adult subjects The main questions it aims to answer are:1. safety profile;2. PK properties 3. PD properties
This is a randomized, double-blind, placebo-controlled, single ascending dose, phase 1 study designed to evaluate the safety, tolerability, PK, PD (anti-VZV antibody level), and immunogenicity of TNM005, as well as to characterize the PD of VARIZIG, in healthy adult volunteers. The study also includes a cohort in which eight subjects will receive a single dose of VARIZIG 625 IU. This cohort will be conducted in an open-label fashion and may be initiated as early as the first TNM005 cohort is dosed. The study include periods of Screening (up to 28 days), in-patient (treatment on Day 1), and safety follow-up until Day 120.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
48
ICON, plc
Salt Lake City, Utah, United States
RECRUITINGIncidence of AEs
Time frame: Up to 120 days post dosing
Number of participants Physical examinations abnormalities
Physical examination includes assessments of general appearance, skin, lymph nodes, head.neck, lung, heart, abdomen, spine, extremities, nervous system, etc.
Time frame: Up to 120 days post dosing
Number of participants with abnormalities of vital signs
Vital signs measured include blood pressure, pulse rate, temperature, and respiration rate.
Time frame: Up to 120 days post dosing
Number of participants with abnormalities of 12-lead electrocardiogram (ECG) parameters
ECG parameters include heart rate, PR interval, RR interval, ORS duration, QTcF interval.
Time frame: Up to 120 days post dosing
Number of participants with abnormalities of clinical laboratory tests
Clinical laboratory tests include hematology, biochemistry, coagulation, and urinalysis.
Time frame: Up to 120 days post dosing
AUC0-t
Area under the plasma concentration-time curve from time 0 (predose) to the last time point with a detectable plasma concentration (Tlast.).
Time frame: Up to 120 days post dosing
AUC0-∞
Area under the plasma concentration-time curve from time 0 (predose) extrapolated to infinite time.
Time frame: Up to 120 days post dosing
Cmax
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Maximum plasma concentration
Time frame: Up to 120days post dosing
Tmax
Time to reach maximum plasma concentration
Time frame: Up to 120 days post dosing
t1/2
Elimination half-life
Time frame: Up to 120days post dosing
λz
Terminal disposition rate constant
Time frame: Up to 120days post dosing
CL/F
Apparent clearance
Time frame: Up to 120days post dosing
Vd/F
Apparent volume of distribution
Time frame: Up to 120days post dosing
t1/2 of anti-varicella-zoster virus (VZV) antibody level (both baseline corrected and uncorrected)
Elimination half-life of antibody level of anti-VZV
Time frame: Up to 120days post dosing
ADA
Incidence of anti-drug antibody (ADA) to TNM005 in serum
Time frame: Up to 120days post dosing