A Controlled Phase 2a Study to Evaluate the Efficacy of EDP-323 Against Respiratory Syncytial Virus Infection in a Virus Challenge Model

December 6, 2023 updated by: Enanta Pharmaceuticals, Inc

A Randomized, Phase 2a, Double-blind, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Antiviral Activity of Multiple Doses of Orally Administered EDP-323 Against Respiratory Syncytial Virus Infection in a Virus Challenge Model in Healthy Adults

A randomized, Phase 2a, double-blind, placebo-controlled study to evaluate the safety, pharmacokinetics and antiviral activity of multiple doses of orally administered EDP-323 in healthy subjects infected with RSV-A Memphis 37b. This study is designed to assess the antiviral effect of EDP-323 compared to a placebo control in the respiratory syncytial virus challenge model.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

114

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • London, United Kingdom
        • Recruiting
        • hVIVO Services Limited
        • Contact:
          • Victoria Parker, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • An informed consent document signed and dated by the subject.
  • Age 18 to 55 years, inclusive.
  • In good health with no history of major medical conditions.
  • A total body weight ≥ 50 kg and Body Mass Index (BMI) ≥ 18 kg/m2 and ≤ 35kg/m2.

Exclusion Criteria:

  • Pregnant or nursing females
  • Acute or chronic medical illness
  • History of, or currently active, symptoms or signs suggestive of upper or lower respiratory tract (URT or LRT) infection within 4 weeks prior to the first study visit.
  • Abnormal lung function
  • Positive for HIV, active hepatitis B or C test
  • Nose or nasopharynx abnormalities
  • Receipt of any investigational drug within 3 months prior to the planned date of viral challenge/first dose of study drug

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EDP-323 Arm A
Subjects will take EDP-323 Dose 1 orally for 5 days
Drug: EDP-323 Dose Regimen 1
EDP-323 capsule
Experimental: EDP-323 Arm B
Subjects will take EDP-323 Dose 2 orally for 5 days
Drug: EDP-323 Dose Regimen 2
EDP-323 capsule
Placebo Comparator: Placebo Arm C
Subjects will take matching placebo orally for 5 days
Drug: Placebo
Placebo capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in viral load measurements
Time Frame: Post initial dose of EDP-323 up to Day 12
Area under the curve for RSV viral load as measured by RT-qPCR assay from the first viral load measurement post initial dose of EDP-323 or placebo through day 12
Post initial dose of EDP-323 up to Day 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Total Symptom Score (TSS)
Time Frame: Innoculation through Day 12
Area Under the Curve (AUC) of TSS through Day 12
Innoculation through Day 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Enanta Pharmaceuticals, Inc

Collaborators

hVIVO Services Limited

Investigators

  • Study Director: Enanta Pharmaceuticals, Inc, Enanta Pharmaceuticals, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2023

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

November 27, 2023

First Submitted That Met QC Criteria

December 6, 2023

First Posted (Estimated)

December 14, 2023

Study Record Updates

Last Update Posted (Estimated)

December 14, 2023

Last Update Submitted That Met QC Criteria

December 6, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EDP 323-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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