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

Phase 2

Completed

• Conditions: RSV Infection
• Interventions: Drug: EDP-323 Dose Regimen 1; Drug: EDP-323 Dose Regimen 2; Drug: Placebo

• Registration Number: NCT06170242
• Lead Sponsor: Enanta Pharmaceuticals, Inc

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-20
• Study First Submitted: 2023-11-27
• Study First Submitted QC: 2023-12-06
• Study First Posted: 2023-12-14
• Primary Completion: 2024-06-17
• Study Completion: 2024-07-12
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-13
• Last Update Posted: 2024-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EDP-323 Arm A	EDP-323 Dose Regimen 1	Subjects will take EDP-323 Dose 1 orally for 5 days
EDP-323 Arm B	EDP-323 Dose Regimen 2	Subjects will take EDP-323 Dose 2 orally for 5 days
Placebo Arm C	Placebo	Subjects will take matching placebo orally for 5 days

Primary Outcome Measures

Name	Time	Method
Change in viral load measurements	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

Secondary Outcome Measures

Name	Time	Method
Change in Total Symptom Score (TSS)	Innoculation through Day 12	Area Under the Curve (AUC) of TSS through Day 12

Trial Locations

Locations (1)

hVIVO Services Limited; 🇬🇧 London, United Kingdom