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Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts 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.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

ICON Early Phase
San Antonio, Texas 78209
Contact:
Shannon Kirk
Shannon.Kirk@iconplc.com

More Details

Status
Recruiting
Sponsor
Enanta Pharmaceuticals, Inc

Study Contact

Enanta Pharmaceuticals, Inc
(617) 607-0800
emartin@enanta.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.