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NCT Number: NCT07540910

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON Early Phase

San Antonio, Texas, 78209, United States

Location status: Recruiting

Location contact

Cassandra Key, MD

PRINCIPAL_INVESTIGATOR

Shannon

CONTACT

[email protected]

9134102258

Shannon Kirk

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

EDP-978

Drug

Oral administration

Placebo

Drug

Placebo to match EDP-978, oral administration

Primary outcomes

  1. Safety measured by adverse events

    Time frame: Up to 8 Days in SAD Cohorts

  2. Safety measured by adverse events

    Time frame: Up to 28 Days in MAD Cohorts

Secondary outcomes

  1. Cmax of EDP-978

    Time frame: Up to 5 Days in SAD Cohorts

  2. AUC of EDP-978

    Time frame: Up to 5 Days in SAD Cohorts

  3. Cmax of EDP-978

    Time frame: Up to 18 Days in MAD Cohorts

  4. AUC of EDP-978

    Time frame: Up to 18 Days in MAD Cohorts

  5. Cmax of EDP-938 (FE)

    Time frame: Up to 12 Days in FE SAD Cohort

    Food effects on plasma PK parameters of EDP-978

  6. AUC of EDP-938 (FE)

    Time frame: Up to 12 Days in FE SAD Cohort

    Food effects on plasma PK parameters of EDP-978

Study contacts

Contact information is provided by the study sponsor or research team.

Enanta Pharmaceuticals, Inc

CONTACT

[email protected]

(617) 607-0800

Sponsors and collaborators

Lead sponsor

Enanta Pharmaceuticals, Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 21, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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