The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-4729 injection in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
103
HRS-4729 injection
HRS-4729 injection placebo
HRS9531 injection
Jinan Central Hospital
Jinan, Shandong, China
RECRUITINGAdverse events (AEs)
Time frame: Screening period up to day 43.
The maximum plasma concentration (Cmax)
Time frame: Post-dose at day 1 to day 43.
Time to maximum plasma concentration (Tmax)
Time frame: Post-dose at day 1 to day 43.
Terminal half-life (t1/2)
Time frame: Post-dose at day 1 to day 43.
Apparent clearance (CL/F)
Time frame: Post-dose at day 1 to day 43.
Apparent volume of distribution (Vz/F)
Time frame: Post-dose at day 1 to day 43.
Anti-HRS-4729 antibodies
Time frame: Post-dose at day 1 to day 43.
Changes from baseline in Fasting Body Weight
Time frame: Run-in Period up to Day 113.
Changes from baseline in Fasting Plasma Glucose
Time frame: Run-in Period up to Day 113.
Changes from baseline in Fasting Insulin
Time frame: Run-in Period up to Day 113.
Changes from baseline in Fasting C-Peptide
Time frame: Run-in Period up to Day 113.
Total fat mass
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HRS9531 injection placebo
Acetaminophen
Time frame: Run-in Period up to Day 113.