Therapeutic: EDP-323, in clinical development as a potential treatment for RSV infection

Trial Status: Actively recruiting

Trial Information: This randomized, double-blind, sponsor-open, placebo-controlled study is assessing the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of EDP-323 in healthy adult subjects. Approximately 82 healthy subjects aged 18 to 65 years old will be enrolled. The first phase of the study assesses single ascending doses of EDP-323 or placebo in healthy subjects. A “fasted” and “fed” two-part cohort will also assess food effect. The second phase of the study assesses multiple ascending doses of EDP-323 or placebo for seven days in healthy subjects.

To be included in the study, subjects must have no clinically relevant history of illness or disease. Subjects cannot have infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) at screening and infection with SARS-CoV-2 at the Day 1 visit. Pregnant or nursing females and current tobacco smokers cannot participate.

For more information, visit ClinicalTrials.gov Identifier: NCT05587478