This study is designed to evaluate the safety, tolerability, PK and PD of GenSci136 in a randomized, double-blind, placebo-controlled trial involving healthy adult participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
48
Huashan Hospital
Shanghai, Shanghai Municipality, China
RECRUITING● Incidence and severity of treatment-emergent adverse events (TEAEs) ● Incidence and severity of serious adverse events (SAEs)
Time frame: Day1-Day113
Serum Concentration of free GenSci136/total GenSci136
Serum concentrations at different time points will be listed and summarized by descriptive statistics.
Time frame: Day1-Day113
Maximum serum concentration (Cmax)
PK parameters will be analyzed by non-compartmental analysis with WinNonlin@ version 8.3 or above.
Time frame: Day1-Day113
Time to maximum serum concentration (Tmax)
PK parameters will be analyzed by non-compartmental analysis with WinNonlin@ version 8.3 or above.
Time frame: Day1-Day113
Area under the concentration-time curve from the time zero to last measurable concentration (AUC0-t)
PK parameters will be analyzed by non-compartmental analysis with WinNonlin@ version 8.3 or above.
Time frame: Day1-Day113
Area under concentration-time from time zero to infinity (AUC0-inf)
PK parameters will be analyzed by non-compartmental analysis with WinNonlin@ version 8.3 or above.
Time frame: Day1-Day113
Terminal elimination half-life (t1/2)
PK parameters will be analyzed by non-compartmental analysis with WinNonlin@ version 8.3 or above.
Time frame: Day1-Day113
Clearance (CL/F)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
PK parameters will be analyzed by non-compartmental analysis with WinNonlin@ version 8.3 or above.
Time frame: Day1-Day113
Apparent volume of distribution (Vd/F)
PK parameters will be analyzed by non-compartmental analysis with WinNonlin@ version 8.3 or above.
Time frame: Day1-Day113
● Changes from baseline in free and total a proliferation inducing ligand (APRIL) levels; ● Changes from baseline in free and total B-cell activating factor (BAFF) levels.
Time frame: Day1-Day113
Incidence and the time of anti-drug antibody (ADA) positive after GenSci136 administration.
Time frame: Day1-Day113