Status:
COMPLETED
A Controlled Phase 2a Study to Evaluate the Efficacy of EDP-323 Against Respiratory Syncytial Virus Infection in a Virus Challenge Model
Lead Sponsor:
Enanta Pharmaceuticals, Inc
Collaborating Sponsors:
hVIVO Services Limited
Conditions:
RSV Infection
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
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 infe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 12 2024
Estimated Enrollment :
142 Patients enrolled
Trial Details
Trial ID
NCT06170242
Start Date
November 20 2023
End Date
July 12 2024
Last Update
October 7 2025
Active Locations (1)
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1
hVIVO Services Limited
London, United Kingdom