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

Phase

Condition

Respiratory Syncytial Virus (Rsv) Infection

Respiratory Syncytial Virus (Rsv)

Treatment

EDP-323 Dose Regimen 1

Placebo

EDP-323 Dose Regimen 2

Clinical Study ID

NCT06170242

EDP 323-101

Ages 18-55
All Genders
Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

Pregnant or nursing females
Acute or chronic medical illness
History of, or currently active, symptoms or signs suggestive of upper or lowerrespiratory tract (URT or LRT) infection within 4 weeks prior to the first studyvisit.
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 ofviral challenge/first dose of study drug

Study Design