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NCT07540910PHASE1RecruitingAccepts Healthy Volunteers

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

Enanta Pharmaceuticals, Inc

Start Date

4/1/2026

Completion Date

11/1/2026

Summary

This study is a randomized, double-blind, sponsor-open, placebo-controlled study. It will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered single and multiple doses of EDP-978 in healthy adult subjects.

Eligibility Criteria

Age Range: 18 years to 65 years

Inclusion Criteria: * An informed consent document signed and dated by the subject. * Healthy male and female subjects of any ethnic origin between the ages of 18 and 65 years, inclusive. Exclusion Criteria: * Clinically relevant evidence or history of illness or disease. * 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. * History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection. * A positive urine drug screen at screening or Day -1. * Current tobacco smokers or use of tobacco within 3 months prior to screening. * Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy). * History of regular alcohol consumption. * Receipt of any vaccine, an investigational agent or biological product within 28 days or 5 times the t½, whichever one is longer, prior to first dose.

Interventions

DRUG

EDP-978

DRUG

Placebo

Interested in This Trial?

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Conditions

Chronic Inducible UrticariaChronic Spontaneous Urticaria

Locations

ICON Early Phase

San Antonio, Texas 78209

United States