Phase 1 Study of HW201877 Capsules to Assess Safety, Tolerability, and Food Effects in Healthy Adults Aged 18 to 55

What this Trial Is About

Researchers are conducting a Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics how the drug moves through the body, pharmacodynamics how the drug affects the body, and the effect of food on HW201877 in healthy adult volunteers aged 18 to 55 years. This study compares HW201877 with a placebo to better understand how the drug behaves and its safety profile in people without inflammatory bowel disease or other health issues. Participants receive either single or multiple oral doses of HW201877 capsules or matching placebo capsules. The study includes a single ascending dose part with a two-period crossover to assess the food effect, followed by a multiple ascending dose part. Each dosing period tests increasing amounts of the drug or placebo to monitor effects and tolerability. During the trial, participants will be closely monitored from Day 1 to Day 5 for any treatment-emergent adverse events and their severity. Assessments include clinical evaluations and laboratory tests to ensure participant safety. The study lasts for a few days of dosing and observation, with participants fully informed and consenting before joining. The sponsor is Wuhan Humanwell Innovative Drug Research and Development Center Limited Company.

A Phase I Study of HW201877 in Healthy Subjects