The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single intravenous administration of SHR-1707 in healthy young adult and elderly subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
63
The second Hospital of Anhui Medical University
Hefei, Anhui, China
Incidence and Severity of Adverse Events as a Measure of Safety and Tolerability
Incidence and severity of adverse events
Time frame: Start of Treatment to end of study (approximately 12 weeks)
Area under the concentration-time curve from time 0 to last time point (AUC0-last) after SHR-1707 administration
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)
Area under the concentration-time curve from time 0 to infinity (AUC0-inf) after SHR-1707 administration
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)
Time to Cmax (Tmax) of SHR-1707
Time to Cmax of SHR-1707
Time frame: Start of Treatment to end of study (approximately 12 weeks)
Maximum observed concentration (Cmax) of SHR-1707
Maximum observed concentration of SHR-1707
Time frame: Start of Treatment to end of study (approximately 12 weeks)
Terminal elimination half-life (t1/2) of SHR-1707
Terminal elimination half-life of SHR-1707
Time frame: Start of Treatment to end of study (approximately 12 weeks)
Clearance (CL) of SHR-1707
Clearance of SHR-1707
Time frame: Start of Treatment to end of study (approximately 12 weeks)
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A single dose of matching SHR-1707 placebo by intravenous (IV) infusion in elderly subjects.
Volume of distribution (Vss) of SHR-1707
Volume of distribution of SHR-1707
Time frame: Start of Treatment to end of study (approximately 12 weeks)
Mean residence time (MRT) of SHR-1707
Mean residence time of SHR-1707
Time frame: Start of Treatment to end of study (approximately 12 weeks)
The change from baseline in plasma Aβ40 and Aβ42 concentrations
The change from baseline in plasma Aβ40 and Aβ42 concentrations will be measured to determine the degree of change over time.
Time frame: Start of Treatment to end of study (approximately 12 weeks)
Number of subjects with Anti-SHR-1707 antibodies
Number of subjects with positive ADA titers over time for SHR-1707
Time frame: Start of Treatment to end of study (approximately 12 weeks)