Phase 1 Study Evaluating a Single Oral Dose of HRS-3095 in Healthy Adults Aged 18 to 55

What this Trial Is About

Researchers are evaluating the safety, pharmacokinetics PK, and pharmacodynamics PD of a single oral dose of HRS-3095 in healthy adults aged 18 to 55. This early-phase 1 study aims to understand how the body processes the drug and its effects, with a particular focus on treatment emergent adverse events by day 8 after dosing. Participants will receive a single oral dose of HRS-3095 or placebo at one of three different dose levels. The study uses a randomized, quadruple-masked, parallel design to compare these groups. The intervention is given once, and participants will be closely monitored during the study period. During the trial, participants will undergo safety assessments to track any adverse events until day 8. Pharmacokinetic measurements such as Cmax, AUC, Tmax, and half-life will be collected by day 4, along with pharmacodynamic evaluations on day 8. The study duration allows for careful monitoring and data collection following the single-dose administration, with total participation lasting until the primary completion date in October 2026.

A Trial of HRS-3095 in Healthy Volunteers