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Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 18 to 65

Testing single and multiple oral doses of EDP-978 in healthy adults

Official title: A Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, First-In-Human, Phase 1 Study of Orally Administered EDP-978 to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses, Multiple Ascending Doses, and the Effect of Food on EDP-978 Pharmacokinetics in Healthy Adult Participants

Run by Enanta Pharmaceuticals, Inc · NCT07540910 · Data updated 2026-11-12

This study will test how safe and tolerable single and multiple oral doses of EDP-978 are in healthy adults and will measure how the body absorbs and responds to the drug.

More Chronic Spontaneous Urticaria trials

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment98 (estimated)
SponsorEnanta Pharmaceuticals, Inc
Industry-sponsored
Locations1 site (San Antonio, Texas)
StatusRecruiting
StartedApril 1, 2026
Main results expectedNovember 2026
Study endsNovember 2026
Registry record updatedApril 21, 2026
Trial IDNCT07540910 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Healthy men and women aged 18 to 65 without clinically relevant medical conditions, not pregnant or nursing, negative for HIV/HBV/HCV/SARS-CoV-2, non-smokers, and able to comply with in-clinic stays and study procedures are ideal candidates.

Probably not a fit

People with active disease, symptomatic urticaria, pregnant or breastfeeding individuals, current smokers, those with recent infections or positive drug screens, or anyone excluded by the criteria are unlikely to receive any direct clinical benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, sponsor-open, placebo-controlled Phase 1 study uses single ascending dose (SAD) and multiple ascending dose (MAD) cohorts to characterize the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of orally administered EDP-978 in healthy adults aged 18–65. Participants are healthy volunteers screened for infections, recent vaccinations, tobacco or drug use, pregnancy, and other conditions that could affect absorption or safety. Subjects will receive either EDP-978 or placebo with close clinical and laboratory monitoring and scheduled PK/PD sampling to define dose-exposure-response relationships. The study is sponsored by Enanta Pharmaceuticals and conducted at ICON Early Phase in San Antonio, Texas.

Why it matters

Potential benefit: If successful, the study could define safe dosing and early human PK/PD for EDP-978, enabling future trials that might lead to new treatments for conditions like urticaria.

How similar studies have gone: This is a first-in-human (first-in-human) SAD/MAD trial for EDP-978, so the specific compound is untested in humans, although SAD/MAD designs are a standard approach in early drug development.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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.

Where it's running

  • ICON Early Phase
    San Antonio, Texas, United States     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.