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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07540910

Enrollment

Registered

2026-04-21

Start date

2026-04-01

Completion date

2026-11-01

Last updated

2026-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Inducible Urticaria, Chronic Spontaneous Urticaria

Keywords

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

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.

Interventions

DRUGEDP-978

Oral administration

DRUGPlacebo

Placebo to match EDP-978, oral administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Safety measured by adverse events	Up to 8 Days in SAD Cohorts

Secondary

Measure	Time frame	Description
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-938 (FE)	Up to 12 Days in FE SAD Cohort	Food effects on plasma PK parameters of EDP-978
AUC of EDP-938 (FE)	Up to 12 Days in FE SAD Cohort	Food effects on plasma PK parameters of EDP-978

Countries

United States

Contacts

CONTACTEnanta Pharmaceuticals, Inc

emartin@enanta.com(617) 607-0800

STUDY_DIRECTOREnanta Pharmaceuticals, Inc

Enanta Pharmaceuticals, Inc

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 22, 2026