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
Conditions
Chronic Inducible UrticariaChronic Spontaneous Urticaria
Locations
ICON Early Phase
San Antonio, Texas 78209
United States