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

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

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.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 98 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Enanta Pharmaceuticals, Inc (Industry-sponsored)
• Locations: 1 site (San Antonio, Texas)
• Trial ID: NCT07540910 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

San Antonio, Texas

• ICON Early Phase — San Antonio, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Enanta Pharmaceuticals, Inc

Conditions Chronic Inducible Urticaria; Chronic Spontaneous Urticaria; First-in-Human; Single Ascending Dose; Multiple Ascending Dose; Healthy Participant