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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05587478
Other study ID # EDP 323-001
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 29, 2022
Est. completion date March 29, 2023

Study information

Verified date October 2022
Source Enanta Pharmaceuticals, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is a randomized, double-blind, sponsor-open, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of orally administered single and multiple doses of EDP-323 in healthy adult subjects.


Recruitment information / eligibility

Status Completed
Enrollment 82
Est. completion date March 29, 2023
Est. primary completion date March 29, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
EDP-323
Oral administration
Placebo
Placebo to match EDP-323, oral administration

Locations

Country Name City State
United States ICON, plc. Lenexa Kansas

Sponsors (1)

Lead Sponsor Collaborator
Enanta Pharmaceuticals, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety measured by adverse events Up to 8 Days in SAD Cohorts
Primary Safety measured by adverse events Up to 14 Days in MAD Cohorts
Secondary Cmax of EDP-323 Up to 5 Days in SAD Cohorts
Secondary AUC of EDP-323 Up to 5 Days in SAD Cohorts
Secondary Cmax of EDP-323 Up to 11 Days in MAD Cohorts
Secondary AUC of EDP-323 Up to 11 Days in MAD Cohorts
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