Ireland
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Recruiting Phase 1

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

NCT07540910 · tracked via the Priya Life Science USA tracker
Sponsor
Enanta Pharmaceuticals, Inc
Phase
Phase 1
Started
2026-04-01
Last updated
2026-04-21

Condition(s) studied

Chronic Inducible UrticariaChronic Spontaneous Urticaria

Investigational drug(s) / intervention(s)

EDP-978Placebo

EDP-978: Oral administration

Placebo: Placebo to match EDP-978, oral administration

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Safety measured by adverse events — Up to 8 Days in SAD Cohorts
  • Safety measured by adverse events — Up to 28 Days in MAD Cohorts

Trial sites (1)

FacilityCityRegionStatus
ICON Early Phase San Antonio Texas Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07540910 on ClinicalTrials.gov ↗ ← All trials in the USA