This project is divided into a single dose escalation and a multiple dose escalation phase Ia clinical study. This is a single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetic characteristics of TQH2929 injection in healthy adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
TQH2929 injection is a humanized monoclonal antibody that interfering with the signal cascade.
Placebo comparator
Peking University First Hospital
Beijing, Beijing Municipality, China
Adverse events (AE) rate
The occurrence of all adverse events (AE).
Time frame: Single dose: Up to Day 113
Serious adverse events (SAE) rate
The occurrence of all adverse events (SAE).
Time frame: Single dose: Up to Day 113
Treatment-related adverse events (TRAE) rate
The occurrence of all treatment-related adverse events (TRAE).
Time frame: Single dose: Up to Day 113
Incidence of clinical laboratory abnormalities
Proportion of subjects with clinical laboratory abnormalities
Time frame: Single administration dose (SAD) group: up to Day 113
Time to reach maximum observed serum concentration (Tmax), SAD
Time to reach maximum (peak) serum concentration after administration in SAD group
Time frame: 1 hour pre-dose, 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours postdose.
Maximum serum concentration (Cmax), SAD
The maximum observed serum concentration of study drug in SAD group.
Time frame: 1 hour pre-dose, 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours postdose.
Area under the concentration-time curve from zero to infinity (AUC 0-∞), SAD
Area under the concentration-time curve of the TQH2929 Injection in serum over the time interval from 0 extrapolated to infinity in SAD group.
Time frame: 1 hour pre-dose, 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours postdose.
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Area under the concentration-time curve from 0 to last observation (AUC 0-t), SAD
Area under the concentration-time curve of the TQH2929 Injection in serum over the time interval from 0 extrapolated to the last quantifiable data time-point in SAD group.
Time frame: 1 hour pre-dose, 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours postdose.
Apparent volume of distribution (Vd/F), SAD
Apparent volume of distribution of the TQH2929 Injection in serum in SAD group.
Time frame: 1 hour pre-dose, 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours postdose.
Apparent clearance (CL/F), SAD
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body, in SAD group.
Time frame: 1 hour pre-dose, 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours postdose.
Half-life (t1/2), SAD
The time required for half of the drug to be eliminated from the serum in SAD group.
Time frame: 1 hour pre-dose, 0, 0.5, 1, 2, 6, 12, 24, 48, 72, 168, 336, 504, 672, 840, 1008, 1344, 1680, 2016, 2353, 2688 hours postdose.
Anti-drug antibodies (ADA)
Proportion of subjects with a positive ADA reading at any time point during the study.
Time frame: SAD group: 1 hour pre-dose, postdose on Day 15, Day 57, Day 85, Day 113.