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Recruiting Phase 1 NCT07540910

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

Phase 1 – testing safety in a small group of people
Conditions: Chronic Inducible Urticaria Chronic Spontaneous Urticaria

Sponsor: Enanta Pharmaceuticals, Inc

trial.available_in: БГ
Overview
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.
Who can participate
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
EDP-978
DRUG
Placebo
DRUG
Locations 1
United States (1)
ICON Early Phase
San Antonio , Texas
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
No
Start date
01.04.2026
Completion date
01.11.2026
Registry ID
NCT07540910
Source
clinicaltrials.gov
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