Phase I Study of HRS-5817 Injection Given by Subcutaneous Injection in Healthy Adults Aged 18 to 55 With or Without Obesity

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of an investigational drug called HRS-5817 in adults affected by obesity. This Phase I study involves healthy adult volunteers with or without obesity and aims to understand how the body processes this drug and how the drug affects the body. Participants will receive HRS-5817 injection or a placebo, both administered under the skin subcutaneously either as single or multiple doses. The study uses a randomized, quadruple-blind design to compare the effects of the drug versus placebo. The treatment period and monitoring extend up to about 253 days after dosing to closely observe drug behavior and safety. During the study, participants will undergo medical evaluations including vital signs, physical exams, lab tests, and electrocardiograms. Researchers will monitor for adverse events and measure drug levels in the body over time. Participants will be followed up regularly to assess drug clearance, immune response, and overall safety. The total study duration includes screening, treatment, and extended observation periods to ensure thorough assessment.

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-5817 Injection