Recruiting
Phase 1

EDP-978

Sponsor:

Enanta Pharmaceuticals, Inc

Code:

NCT07540910

Conditions

Chronic Inducible Urticaria

Chronic Spontaneous Urticaria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

EDP-978

Placebo

Study Details

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

Study ID

NCT07540910

Start date

Apr 1, 2026

Status verified date

Apr, 2026

Completion date

Nov, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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 Design

Enrollment

98 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

experimental: EDP-978 MAD Cohorts

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

placebo comparator: EDP-978 SAD Placebo Cohorts

Matching placebo, orally, once daily in one single administration

placebo comparator: EDP-978 MAD Placebo Cohorts

Matching placebo, orally, once daily for 14 days

Interventions

EDP-978

Oral administration

Placebo

Placebo to match EDP-978, oral administration

Primary outcome measure

  • Safety measured by adverse events [ Time Frame: Up to 8 Days in SAD Cohorts ]
  • Safety measured by adverse events [ Time Frame: Up to 28 Days in MAD Cohorts ]

Central Contacts and Locations

Central contacts

Enanta Pharmaceuticals, Inc

(617) 607-0800emartin@enanta.com

Locations

ICON Early Phase

Recruiting

San Antonio, Texas, United States, 78209

Contacts

Shannon Kirk

Shannon.Kirk@iconplc.com

Shannon

9134102258shannon.kirk@iconplc.com

Principal Investigator:

Cassandra Key, MD

More Information

Sponsor

Enanta Pharmaceuticals, Inc

Last update posted

Apr 21, 2026

Last verified

Apr, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Enanta Pharmaceuticals, Inc on 2026-04-21.