Actively Recruiting
A Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, First-In-Human Phase 1 Study of Oral EDP-978 to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Healthy Adults
Led by Enanta Pharmaceuticals, Inc · Updated on 2026-04-21
98
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of EDP-978 in healthy adults aged 18 to 65 years. This randomized, double-blind, sponsor-open, placebo-controlled study aims to understand how the body processes and reacts to single and multiple oral doses of EDP-978, a drug being studied for potential use in conditions such as chronic inducible urticaria and chronic spontaneous urticaria. Participants will receive either one of several doses of EDP-978 or a matching placebo. The study includes single ascending dose (SAD) cohorts where one oral dose of EDP-978 or placebo is given daily in a single administration, and multiple ascending dose (MAD) cohorts where doses are given once daily for 14 days. The effects of food on the pharmacokinetics of EDP-978 are also evaluated. During the study, participants will be monitored for safety through adverse event reporting up to 8 days in SAD cohorts and up to 28 days in MAD cohorts. Blood samples will be collected to measure drug concentration levels (Cmax and AUC) over specific durations depending on the cohort. The study involves careful tracking of tolerability, drug absorption, and effects, with a total participation period that varies by cohort.
CONDITIONS
Brief Title
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of EDP-978 in Healthy Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Healthy males and females of any ethnic origin
- Age between 18 and 65 years, inclusive
You will not qualify if you...
- Clinically relevant illness or disease history
- Infection with HIV, hepatitis B, hepatitis C, or SARS-CoV-2
- Pregnant or nursing females
- Febrile illness within 7 days before first dose or active infection
- Positive urine drug screen at screening or Day -1
- Current tobacco use or use within 3 months prior to screening
- Conditions affecting drug absorption like gastrectomy or cholecystectomy
- History of regular alcohol consumption
- Receipt of vaccine, investigational agent, or biological product within 28 days or 5 half-lives prior to first dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 8 days in single administration cohorts and up to 28 days in multiple dose cohorts
Participants receive oral doses of EDP-978 or matching placebo either as a single administration or once daily for up to 14 days.
1 to 2 visits depending on cohort assignment
Trial Site Locations
Total: 1 location
1
ICON Early Phase
San Antonio, Texas, United States, 78209
Actively Recruiting
Research Team
E
Enanta Pharmaceuticals, Inc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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