A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of EDP-978 in Healthy Adults

NCT07540910 | Recruiting Phase 1 FDA Drug

• 1 other identifier: EDP 978-001
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Inducible Urticaria; Chronic Spontaneous Urticaria

Keywords

First-in-Human; Single Ascending Dose; Multiple Ascending Dose; Healthy Participant

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• 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)

  Up to 12 Days in FE SAD Cohort

Study Arms (4)

EDP-978 SAD Cohorts

EXPERIMENTAL

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

EDP-978 MAD Cohorts

EXPERIMENTAL

EDP-978 Dose 1, Dose 2, Dose 3, Dose 4 and Dose 5 orally, once daily for 14 days

Drug: EDP-978

EDP-978 SAD Placebo Cohorts

PLACEBO COMPARATOR

Matching placebo, orally, once daily in one single administration

Drug: Placebo

EDP-978 MAD Placebo Cohorts

PLACEBO COMPARATOR

Matching placebo, orally, once daily for 14 days

Drug: Placebo

Interventions

EDP-978 DRUG

Oral administration

EDP-978 MAD Cohorts; EDP-978 SAD Cohorts

Placebo DRUG

Placebo to match EDP-978, oral administration

EDP-978 MAD Placebo Cohorts; EDP-978 SAD Placebo Cohorts

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Enanta Pharmaceuticals, Inc: lead

Study Sites (1)

ICON Early Phase

San Antonio, Texas, 78209, United States

RECRUITING

MeSH Terms

Conditions

Chronic Inducible Urticaria; Chronic Urticaria

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Enanta Pharmaceuticals, Inc

  Enanta Pharmaceuticals, Inc

  STUDY DIRECTOR

Central Study Contacts

Enanta Pharmaceuticals, Inc

CONTACT

(617) 607-0800; emartin@enanta.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 21, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)