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A Phase 2a Study to Evaluate EDP-938 in the Virus Challenge Model

NCT03691623 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 179

Last updated 2022-05-03

Study results available
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Summary

A randomised, Phase 2a, double-blind, placebo-controlled study to evaluate the safety, pharmacokinetics and antiviral activity of multiple doses of orally administered EDP-938 in healthy subjects infected with RSV-A Memphis 37b. This study is designed to compare the antiviral effect of EDP-938 compared to a placebo control in the respiratory syncytial virus challenge model.

Conditions

  • RSV Infection

Interventions

DRUG

EDP-938 Dose 1

Oral suspension for 5 days

DRUG

EDP-938 Dose 2

Oral suspension for 5 days

DRUG

Placebo

Oral suspension for 5 days

DRUG

EDP-938 Dose 3

Oral suspension for 5 days

DRUG

EDP-938 Dose 4

Oral suspension for 5 days

DRUG

Placebo

Oral suspension for 5 days

Sponsors & Collaborators

  • hVIVO Services Limited

    collaborator INDUSTRY

  • Enanta Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Enanta Pharmaceuticals, Inc · Enanta Pharmaceuticals, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-15
Primary Completion
2019-09-30
Completion
2019-10-18
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT03691623 on ClinicalTrials.gov