This study is designed to evaluate the safety, tolerability, PK and PD of multiple subcutaneous injections of GenSci120 in a randomized, double-blind, placebo-controlled, multiple-ascending-dose phase Ib trial involving healthy adult participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGTEAEs
Incidence and severity of treatment-emergent adverse events
Time frame: 169 days
SAEs
Incidence and severity of serious adverse events
Time frame: 169 days
CSfadf
Clinically significant changes from baseline
Time frame: 169 days
plasma
Concentration of GenSci120 in plasma samples.
Time frame: 169 days
AUC0-t, AUC0-∞
Area under drug concentration-time curve
Time frame: 169 days
Tmax
time to maximum concentration
Time frame: 169 days
Cmax
maximum concentration
Time frame: 169 days
t1/2
169 days
Time frame: half-life
CL/F
169 days
Time frame: apparent clearance
V/F
apparent volume of distribution
Time frame: 169 days
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RO of T cell subset
Receptor occupancy (RO) of T cell subset detected by flow cytometry
Time frame: 169 days
cell counts of T cell subset
cell counts of T cell subset detected by flow cytometry
Time frame: 169 days
Incidence of ADA
Incidence of anti-drug antibody (ADA) positive positive (if applicable) after GenSci120 administration
Time frame: 169 days
Time of ADA
Time of anti-drug antibody (ADA) positive positive (if applicable) after GenSci120 administration
Time frame: 169 days