This study is a randomized, double-blind, placebo-controlled, dose-escalation phase I clinical trial. This study consists of two parts: the single-dose escalation study (SAD) in healthy subjects and the multiple-dose escalation study (MAD) in obese patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
124
SHR-2906 injection, in different doses.
SHR-2906 injection placebo.
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
RECRUITINGIncidence of adverse events (AEs).
Time frame: Part1: 57 days; Part2: 113 days.
Incidence of serious adverse events (SAEs).
Time frame: Part1: 57 days; Part2: 113 days.
Maximum concentration (Cmax).
Time frame: Part1: 57 days; Part2: 113 days.
Time of maximum concentration (Tmax).
Time frame: Part1: 57 days; Part2: 113 days.
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last).
Time frame: Part1: 57 days; Part2: 113 days.
Area under the concentration-time curve from time zero to infinity (AUC0-inf).
Time frame: Part1: 57 days; Part2: 113 days.
Area under the concentration-time curve from time zero to the end of the dosing interval tau (AUC0-tau).
Time frame: Part1: 57 days; Part2: 113 days.
Elimination half-life (t1/2).
Time frame: Part1: 57 days; Part2: 113 days.
Apparent clearance (CL/F).
Time frame: Part1: 57 days; Part2: 113 days.
Apparent volume of distribution (Vz/F).
Time frame: Part1: 57 days; Part2: 113 days.
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