A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of EDP-978 in Healthy Adults
Recruiting now · Phase 1 · Has a placebo group
Conditions studied: Chronic Inducible Urticaria, Chronic Spontaneous Urticaria
In brief
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.
Key facts
- Study ID
- NCT07540910
- Run by
- Enanta Pharmaceuticals, Inc
- People needed
- 98
- Starts
- 2026-04-01
- Expected to finish
- 2026-11-01
- Last updated by the study team
- 2026-04-21
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- ICON Early Phase — San Antonio, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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