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

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

  • Chronic Inducible Urticaria
  • Chronic Spontaneous Urticaria

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