A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple 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 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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Spontaneous Urticaria; Chronic Inducible Urticaria
• Intervention / Treatment: Drug: EDP-978; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 98
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Enanta Pharmaceuticals, Inc; Phone Number: (617) 607-0800; Email: emartin@enanta.com

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78209
      • Recruiting
      • ICON Early Phase
      • Contact: Shannon Kirk; Email: Shannon.Kirk@iconplc.com
      • Contact: Shannon; Phone Number: 9134102258; Email: shannon.kirk@iconplc.com
      • Principal Investigator: Cassandra Key, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EDP-978 SAD Cohorts; EDP-978 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5, Dose 6 and Dose 7, orally daily in one single administration	Drug: EDP-978; Oral administration
Experimental: EDP-978 MAD Cohorts; EDP-978 Dose 1, Dose 2, Dose 3, Dose 4 and Dose 5 orally, once daily for 14 days	Drug: EDP-978; Oral administration
Placebo Comparator: EDP-978 SAD Placebo Cohorts; Matching placebo, orally, once daily in one single administration	Drug: Placebo; Placebo to match EDP-978, oral administration
Placebo Comparator: EDP-978 MAD Placebo Cohorts; Matching placebo, orally, once daily for 14 days	Drug: Placebo; Placebo to match EDP-978, oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety measured by adverse events	Up to 8 Days in SAD Cohorts
Safety measured by adverse events	Up to 28 Days in MAD Cohorts

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax of EDP-978		Up to 5 Days in SAD Cohorts
AUC of EDP-978		Up to 5 Days in SAD Cohorts
Cmax of EDP-978		Up to 18 Days in MAD Cohorts
AUC of EDP-978		Up to 18 Days in MAD Cohorts
Cmax of EDP-938 (FE)	Food effects on plasma PK parameters of EDP-978	Up to 12 Days in FE SAD Cohort
AUC of EDP-938 (FE)	Food effects on plasma PK parameters of EDP-978	Up to 12 Days in FE SAD Cohort

Collaborators and Investigators

• Sponsor: Enanta Pharmaceuticals, Inc
• Investigators: Study Director: Enanta Pharmaceuticals, Inc, Enanta Pharmaceuticals, Inc

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: April 13, 2026
• First Submitted That Met QC Criteria: April 17, 2026
• First Posted (Actual): April 21, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: First-in-Human; Single Ascending Dose; Multiple Ascending Dose; Healthy Participant
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Urticaria; Skin Diseases, Vascular; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Chronic Urticaria; Chronic Inducible Urticaria
• Other Study ID Numbers: EDP 978-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No