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

RSV Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06170242
• Other study ID #: EDP 323-101
• Status: Recruiting
• Phase: Phase 2
• Start date: November 20, 2023
• Est. completion date: June 2024

Study information

• Verified date: November 2023
• Source: Enanta Pharmaceuticals, Inc
• Contact: Enanta Pharmaceuticals, Inc
• Phone: (617) 607-0800
• Email: jdevincenzo[@]enanta.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 114
• Est. completion date: June 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Respiratory Syncytial Virus Infections
• RSV Infection
• Virus Diseases

Intervention

Drug:
• EDP-323 Dose Regimen 1
EDP-323 capsule
• EDP-323 Dose Regimen 2
EDP-323 capsule
• Placebo
Placebo capsule

Locations

Country	Name	City	State
United Kingdom	hVIVO Services Limited	London

Sponsors (2)

Lead Sponsor	Collaborator
Enanta Pharmaceuticals, Inc	hVIVO Services Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in viral load measurements	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	Change in Total Symptom Score (TSS)	Area Under the Curve (AUC) of TSS through Day 12	Innoculation through Day 12