The purpose of this study is to assess safety, PK, Pharmacodynamic and immunogenicity profile of a single dose of HRS-5817 in obese participants
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
Linear
Perth, Western Australia, Australia
Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events
Number of participants with Adverse events and Serious adverse events
Time frame: Day 253
Pharmacokinetics - Cmax
Maximum observed plasma concentration (Cmax)
Time frame: Day 253
Pharmacokinetics - AUC₀-t
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC₀-inf)
Time frame: Day 253
Pharmacokinetics - Tmax
Time to reach maximum observed plasma concentration (Tmax)
Time frame: Day 253
Pharmacokinetics - t½
Terminal elimination half-life (t½)
Time frame: Day 253
Immunogenicity - Anti-Drug Antibody (ADA)
Incidence and onset time of anti-drug antibody (ADA)
Time frame: Day 253
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Single dose of HRS-5817/placebo given subcutaneously (dose level 4)