Phase 1 Study to Evaluate Safety, Tolerability, and How the Body Processes Single and Multiple Oral Doses of EDP-978 in Healthy Adults Aged 18 to 65

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of EDP-978 in healthy adults aged 18 to 65 years. This randomized, double-blind, sponsor-open, placebo-controlled study aims to understand how the body processes and reacts to single and multiple oral doses of EDP-978, a drug being studied for potential use in conditions such as chronic inducible urticaria and chronic spontaneous urticaria. Participants will receive either one of several doses of EDP-978 or a matching placebo. The study includes single ascending dose SAD cohorts where one oral dose of EDP-978 or placebo is given daily in a single administration, and multiple ascending dose MAD cohorts where doses are given once daily for 14 days. The effects of food on the pharmacokinetics of EDP-978 are also evaluated. During the study, participants will be monitored for safety through adverse event reporting up to 8 days in SAD cohorts and up to 28 days in MAD cohorts. Blood samples will be collected to measure drug concentration levels Cmax and AUC over specific durations depending on the cohort. The study involves careful tracking of tolerability, drug absorption, and effects, with a total participation period that varies by cohort.

A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of EDP-978 in Healthy Adults