This is a Phase 1a, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of STSP-0902.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
Subjects will receive the administration dose on Day 0 following protocol requirements
Subjects will receive the administration dose on Day 0 following protocol requirements
Peking University Third Hospital
Beijing, Beijing Municipality, China
Number of treatment-related adverse events as assessed by CTCAE 5.0
To evaluate the safety and tolerability of STSP-0902 injection in healthy adult subjects
Time frame: 28 days
Maximum Concentration (Cmax)
To evaluate the pharmacokinetics (PK) of STSP-0902
Time frame: Pre-dose; after dose: 2 hours, 6 hours, 10 hours, 14 hours, 24 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 336 hours, 28 days
Area under the plasma concentration-time curve (AUC0-t)
To evaluate the pharmacokinetics (PK) of STSP-0902
Time frame: Pre-dose; after dose: 2 hours, 6 hours, 10 hours, 14 hours, 24 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 336 hours, 28 days
Area under the curve from time 0 extrapolated to infinite time (AUC0-∞)
To evaluate the pharmacokinetics (PK) of STSP-0902
Time frame: Pre-dose; after dose: 2 hours, 6 hours, 10 hours, 14 hours, 24 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 336 hours, 28 days
Time to peak Concentration (Tmax)
To evaluate the pharmacokinetics (PK) of STSP-0902
Time frame: Pre-dose; after dose: 2 hours, 6 hours, 10 hours, 14 hours, 24 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 336 hours, 28 days
Elimination Phase Half-life (t1/2)
To evaluate the pharmacokinetics (PK) of STSP-0902
Time frame: Pre-dose; after dose: 2 hours, 6 hours, 10 hours, 14 hours, 24 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 336 hours, 28 days
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apparent oral clearance (CL/F)
To evaluate the pharmacokinetics (PK) of STSP-0902
Time frame: Pre-dose; after dose: 2 hours, 6 hours, 10 hours, 14 hours, 24 hours, 48 hours, 72 hours, 120 hours, 168 hours, 240 hours, 336 hours, 28 days
Anti-drug antibody(ADA)
To evaluate the immunogenicity of STSP-0902
Time frame: Pre-dose; after dose: 336 hours, 28 days