The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of recombinant Anti-IL-RAP humanised monoclonal antibody injection in healthy Chinese subjects (Part A) and subjects with acute gout flare (Part B)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
64
* Anti-IL-RAP humanised monoclonal antibody injection * 300 mg (2.0 mL)/vial * Administered in accordance with the study protocol * Single administration only
* Anti-IL-RAP humanised monoclonal antibody placebo injection * 300 mg (2.0 mL)/vial * Administered in accordance with the study protocol * Single administration only
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGIncidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
To investigate the safety characteristics.
Time frame: 12 week
Immunogenic outcome
The incidence of antidrug Antibody (ADA) and/or Neutralising antibodies (NAb)
Time frame: 12 week
AUC
Describing the Area Under Curve
Time frame: 12 Week
Cmax
Describing the Maximum Serum Concentration of Drug
Time frame: 12 Week
CL or CL/F
Describing the Clearance
Time frame: 12 Week
V or V/F
Describing the Apparent Volume of Distribution
Time frame: 12 Week
t1/2
Describing the Half Life
Time frame: 12 Week
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