The study is being conducted to Evaluate the Safety, Tolerability and Pharmacokinetics pharmacodynamics of SHR-2010 by intravenously/subcutaneously in Healthy Subject.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
61
Treatment for intravenously: 6 subjects for SR-2010 injection. Treatment for subcutaneously: 8 subjects for SR-2010 injection.
Treatment for intravenously: 2 subjects for placebo. Treatment for subcutaneously: 2 subjects for placebo.
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Safety and tolerability: Incidence of subjects with adverse events (AEs)
Incidence of AEs, including any abnormal findings in vital signs, and/or physical examination and/or clinical laboratory assessments and/or 12-lead ECG evaluation and/or IGRA.
Time frame: Baseline up to Day 85
Pharmacokinetics (PK) parameter: AUC0-t for SHR-2010
AUC0-t: Area under the plasma concentration-time curve from time zero to the time of last quantifiable analyte concentration
Time frame: Baseline up to Day 85
Pharmacokinetics (PK) parameter: AUC0-∞ for SHR-2010
AUC0-∞: Area under the plasma concentration-time curve from time zero extrapolated to infinity
Time frame: Baseline up to Day 85
Pharmacokinetics (PK) parameter: Cmax for SHR-2010
Cmax: Maximum plasma concentration
Time frame: Baseline up to Day 85
Pharmacokinetics (PK) parameter: Tmax for SHR-2010
Tmax: Time to reach maximum plasma concentration
Time frame: Baseline up to Day 85
Pharmacokinetics (PK) parameter: t1/2 for SHR-2010
t1/2: Terminal half-life
Time frame: Baseline up to Day 85
Pharmacokinetics (PK) parameter: CL of SHR-2010 for administration intravenously
CL: Clearance
Time frame: Baseline up to Day 85
Pharmacokinetics (PK) parameter: CL/F of SHR-2010 for administration subcutaneously
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
CL/F: Apparent clearance
Time frame: Baseline up to Day 85
Pharmacokinetics (PK) parameter: V of SHR-2010 for administration intravenously
V: Volume of distribution
Time frame: Baseline up to Day 85
Pharmacokinetics (PK) parameter: V/F of SHR-2010 for administration subcutaneously
V/F: Apparent volume of distribution
Time frame: Baseline up to Day 85
Pharmacokinetics (PK) parameter: Bioavailability (F) of SHR-2010
Bioavailability of SHR-2010 for administration subcutaneously.
Time frame: Baseline up to Day 85
Pharmacodynamics (PD): C4b level in the serum
C4b level in the serum.
Time frame: Baseline up to Day 85
Immunogenicity: Proportion of anti-drug antibodies (ADA) positive subjects
Proportion of anti-drug antibodies (ADA) positive subjects.
Time frame: Baseline up to Day 85