A Study of EDP-323 in Healthy Subjects

RSV Infection Clinical Trial

Official title:

A Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, First-In- Human Study of Orally Administered EDP-323 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses, Multiple Ascending Doses, and the Effect of Food on EDP-323 Pharmacokinetics in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05587478
• Other study ID #: EDP 323-001
• Status: Completed
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Respiratory Syncytial Virus Infections
• RSV Infection

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