The purpose of this study is to assess safety, PK, Pharmacodynamic and immunogenicity profile of a single dose of SHR-2173 in healthy participants
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
18
Single dose SHR-2173 injection or matching placebo given subcutaneously
Veritus Research
Melbourne, Victoria, Australia
Pharmacokinetics - Cmax
Maximum observed plasma concentration (Cmax)
Time frame: Day 71
Pharmacokinetics - AUC₀-t
Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUC₀-t)
Time frame: Day 71
Pharmacokinetics - AUC₀-inf
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC₀-inf)
Time frame: Day 71
Pharmacokinetics - Tmax
Time to reach maximum observed plasma concentration (Tmax)
Time frame: Day 71
Pharmacokinetics - t½
Terminal elimination half-life (t½)
Time frame: Day 71
Immunogenicity - Anti-Drug Antibody (ADA)
Incidence and onset time of anti-drug antibody (ADA)
Time frame: Day 71
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 71
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