Linear
Perth, Western Australia, 6027, Australia
NCT Number: NCT07238647
The purpose of this study is to assess safety, PK, Pharmacodynamic and immunogenicity profile of a single dose of HRS-5817 in obese participants
This study is active but is not currently recruiting participants.
Notify Me18 year–55 year
All sexes
Interventional
Early Phase 1
Perth, Western Australia, 6027, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Negative pregnancy test for women of childbearing potential (WOCBP) at baseline. Men and WOCBP must agree to take highly effective contraceptive methods
Exclusion criteria
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Single dose of HRS-5817/placebo given subcutaneously (dose level 1 )
Time frame: Day 253
Number of participants with Adverse events and Serious adverse events
Time frame: Day 253
Maximum observed plasma concentration (Cmax)
Time frame: Day 253
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC₀-inf)
Time frame: Day 253
Time to reach maximum observed plasma concentration (Tmax)
Time frame: Day 253
Terminal elimination half-life (t½)
Time frame: Day 253
Incidence and onset time of anti-drug antibody (ADA)
Atridia Pty Ltd.
Industry
A Phase I, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of Subcutaneous Administration of Single Ascending Doses of HRS-5817 in Obese Participants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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