This study is a phase 1 single dose escalation study of SHR-1906 in healthy subjects. The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of SHR-1906 in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
72
Drug: SHR-1906 IV, single dose Drug: Placebo IV, single dose
Phase I Clinical Research Unit, Qianfoshan Hospital of Shandong Province
Jinan, Shandong, China
Adverse events
Incidence and severity of adverse events
Time frame: Start of Treatment to end of study (approximately 10 weeks)
Pharmacokinetics-AUC0-last
Area under the concentration-time curve from time 0 to last time point after SHR-1906 administration
Time frame: Start of Treatment to end of study (approximately 10 weeks)
Pharmacokinetics-AUC0-inf
Area under the concentration-time curve from time 0 to infinity after SHR-1906 administration
Time frame: Start of Treatment to end of study (approximately 10 weeks)
Pharmacokinetics-Tmax
Time to Cmax of SHR-1906
Time frame: Start of Treatment to end of study (approximately 10 weeks)
Pharmacokinetics-Cmax
Maximum observed concentration of SHR-1906
Time frame: Start of Treatment to end of study (approximately 10 weeks)
Pharmacokinetics-CL
Clearance of SHR-1906
Time frame: Start of Treatment to end of study (approximately 10 weeks)
Pharmacokinetics-V
Volume of distribution during terminal phase of SHR-1906
Time frame: Start of Treatment to end of study (approximately 10 weeks)
Pharmacokinetics-t1/2
Terminal elimination half-life of SHR-1906
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Time frame: Start of Treatment to end of study (approximately 10 weeks)
Anti-Drug antibody
The percentage of subjects with positive ADA titers over time for SHR-1906
Time frame: Start of Treatment to end of study (approximately 10 weeks)