A Study to Assess EDP-938 for the Treatment of Acute Upper Respiratory Tract Infection With Respiratory Syncytial Virus in Adult Subjects

NCT04196101 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2023-10-30

Study results available
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Summary

This was a randomized, double-blind, placebo-controlled, multicentre, phase 2 study to evaluate the efficacy, safety and tolerability of orally administered EDP-938 in adults with RSV infection.

Conditions

Interventions

DRUG

EDP-938

Four tablets daily for 5 days

DRUG

Placebo

Four tablets daily for 5 days

Sponsors & Collaborators

  • PPD Development, LP

    collaborator INDUSTRY
  • Enanta Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Scott Rottinghaus, MD · Enanta Pharmaceuticals, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-22
Primary Completion
2022-01-04
Completion
2022-01-04
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Bulgaria
  • New Zealand
  • Poland
  • South Africa
  • Ukraine

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04196101 on ClinicalTrials.gov