A randomized, double-blind, placebo-controlled, single dose escalation phase 1 study to access the Pharmacokinetics and Pharmacodynamics of Single Intravenous Administration of SHR-1707
The study will consist of two parts: Subjects will be randomized to receive SHR-1707 as reflected by the guiding principle for the dose esclation/expansion phase. Each dose group includes a screening period, a baseline period, an observational period, and a safety follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
50
Atridia Pty Limited
Sydney, New South Wales, Australia
Adverse events
Incidence and severity of adverse events
Time frame: Start of Treatment to end of study (approximately 12 weeks)
Pharmacokinetics-AUC0-last
Area under the concentration-time curve from time 0 to last time point after SHR-1707 administration
Time frame: Start of Treatment to end of study (approximately 12 weeks)
Pharmacokinetics-AUC0-inf
Area under the concentration-time curve from time 0 to infinity after SHR-1707 administration
Time frame: Start of Treatment to end of study (approximately 12 weeks)
Pharmacokinetics-Tmax
Time to Cmax of SHR-1707
Time frame: Start of Treatment to end of study (approximately 12 weeks)
Pharmacokinetics-Cmax
Maximum observed concentration of SHR-1707
Time frame: Start of Treatment to end of study (approximately 12 weeks)
Pharmacokinetics-CL/F
Apparent clearance of SHR-1707
Time frame: Start of Treatment to end of study (approximately 12 weeks)
Pharmacokinetics-Vz/F
Apparent volume of distribution during terminal phase of SHR-1707
Time frame: Start of Treatment to end of study (approximately 12 weeks)
Pharmacokinetics-t1/2
Terminal elimination half-life of SHR-1707
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Time frame: Start of Treatment to end of study (approximately 12 weeks)
Pharmacokinetics MRT
Mean residence time of SHR-1707
Time frame: Start of Treatment to end of study (approximately 12 weeks)
Pharmacodynamics
Change from baseline of plasma biomarker concentrations
Time frame: Start of Treatment to end of study (approximately 12 weeks)
Anti-Drug antibody
The percentage of subjects with positive ADA titers over time for SHR-1707.
Time frame: Start of Treatment to end of study (approximately 12 weeks)