This is phase Ia study to research YBSW015 injection which is a monomolecular bispecific antibody. The Primary objective is to evaluate the safety and tolerability of YBSW015 injection after a single intravenous injection at different doses in healthy subjects. The Secondary objective is to evaluate the pharmacokinetic characteristics and immunogenicity of different doses of YBSW015 injection after a single intravenous injection in healthy subjects. This study is a single-center, randomized, double-blind, placebo-controlled, single-dose escalation clinical trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
40
Prepared YBSW015 injection is intravenously injected by an infusion pump or gravity infusion with intravenous infusion of 250 mL for 60 min±10 min.
safety of YBSW015 injection
Evaluation of treatment-emergent adverse event (TEAE) and serious adverse events (SAE) during treatment;
Time frame: from screening visit to the end of the follow-up period, assessed up to 85 days
tolerability of YBSW015 injection
Evaluation of local tolerance: administration site reaction;
Time frame: from screening visit to the end of the follow-up period, assessed up to 85 days
PK parameter
Peak concentration (Cmax) Immunogenicity: To detect the positive rate and titer of anti-drug antibody ADA
Time frame: from screening visit to the end of follow-up period, assessed up to 85 days
PK parameter
peak time (Tmax)
Time frame: from screening visit to the end of follow-up period, assessed up to 85 days
PK parameter
terminal elimination rate constant (λz)
Time frame: from screening visit to the end of follow-up period, assessed up to 85 days
PK parameter
terminal elimination half-life (t1/2)
Time frame: from screening visit to the end of follow-up period, assessed up to 85 days
PK parameter
area under the curve from time zero to the time of the last time of quantifiable concentration (AUC0-t)
Time frame: from screening visit to the end of follow-up period, assessed up to 85 days
PK parameter
area under the concentration-time curve from time zero to infinite time (AUC0-∞)
Time frame: from screening visit to the end of follow-up period, assessed up to 85 days
PK parameter
extrapolated percentage of AUC0-∞ (%AUCex)
Time frame: from screening visit to the end of follow-up period, assessed up to 85 days
PK parameter
apparent clearance (CLz)
Time frame: from screening visit to the end of follow-up period, assessed up to 85 days
PK parameter
apparent volume of distribution (Vz)
Time frame: from screening visit to the end of follow-up period, assessed up to 85 days
PK parameter
mean residence time (MRT)
Time frame: from screening visit to the end of follow-up period, assessed up to 85 days
Immunogenicity
positive rate of anti-drug antibody ADA
Time frame: from screening visit to the end of follow-up period, assessed up to 85 days
Immunogenicity
Titer of anti-drug antibody ADA
Time frame: from screening visit to the end of follow-up period, assessed up to 85 days
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