Phase 1 Study of Safety and Effects of HRS-6257 Drug in Healthy Adults Aged 18 to 55

What this Trial Is About

Researchers are evaluating the safety, tolerability, how the body processes, and the effects of food on the oral drug HRS-6257 in healthy adults aged 18 to 55. This phase 1, randomized, single-blind, placebo-controlled study aims to gather detailed information about how single and multiple doses of HRS-6257 behave in the body and their impact on pain tolerance. Participants will receive either HRS-6257 or a placebo in two parts of the study. The drug is given orally in single and repeated doses to assess its pharmacokinetics and pharmacodynamics. The study includes measurements over time to observe the drugs absorption and effects, including the influence of food on its bioavailability. During the study, participants will be monitored for adverse events from the day they sign consent until Day 14, 21, or 27 depending on the study part. Researchers will assess drug levels in the blood up to 72 hours after dosing, measure pain tolerance using the Cold Pain Test, and evaluate responses related to suicide risk. The total participation involves multiple visits for drug administration and safety evaluations to ensure careful monitoring throughout the trial.

A Study of Single and Multiple Doses of HRS-6257 in Healthy Subjects