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EDP-323 Dose Regimen 1

Phase 2

RSV Infection | Small molecule | Infectious Disease |Enanta Pharmaceuticals, Inc.|Trials Updated: Oct 7, 2025

EDP-323 Dose Regimen 1 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Dec 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment142

FDA Designations

No designations recorded

EDP-323 Dose Regimen 1 clinical trials

EDP-323 Dose Regimen 1 · 1 trial · 1 indication

Phase 2 1
NCT06170242A Controlled Phase 2a Study to Evaluate the Efficacy of EDP-323 Against Respiratory Syncytial Virus Infection in a Virus Challenge ModelRSV Infection
COMPLETED142 Analytics
PHASE2COMPLETED
A Controlled Phase 2a Study to Evaluate the Efficacy of EDP-323 Against Respiratory Syncytial Virus Infection in a Virus Challenge Model
RSV InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

Quantitative Reverse Transcription-polymerase Chain Reaction (qRT-PCR): RSV Area Under the Viral Load-time Curve (VL-AUC)
Day 1 to Day 12

Measured by qRT-PCR in nasal samples.

Secondary Endpoints

qRT-PCR: RSV Peak Viral Load (VLPEAK)
Day 1 to Day 12
qRT-PCR: Time From the Assessment at the Time of the First Dose of IMP to RSV VLPEAK
Day 1 to Day 12
qRT-PCR: Time From the Assessment at the Time of the First Dose of IMP to RSV Viral Load Negativity
Day 1 to Day 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
EDP-323 Arm AEXPERIMENTALSubjects will take EDP-323 Dose 1 orally for 5 days
EDP-323 Arm BEXPERIMENTALSubjects will take EDP-323 Dose 2 orally for 5 days
Placebo Arm CPLACEBO_COMPARATORSubjects will take matching placebo orally for 5 days

Interventions

NameTypeDescription
EDP-323 Dose Regimen 1DRUGEDP-323 capsule
EDP-323 Dose Regimen 2DRUGEDP-323 capsule
PlaceboDRUGPlacebo capsule
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 nu...

Countries:United Kingdom
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Frequently asked questions about EDP-323 Dose Regimen 1

What is EDP-323 Dose Regimen 1 used for?

EDP-323 Dose Regimen 1 is being developed for the treatment of respiratory syncytial virus (RSV) infection. It is an investigational small molecule antiviral from Enanta Pharmaceuticals, studied in a controlled human viral challenge model rather than in naturally infected patients.

Who is developing EDP-323 Dose Regimen 1?

EDP-323 Dose Regimen 1 is being developed by Enanta Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker ENTA. Enanta is the sponsor of the clinical program evaluating this RSV antiviral candidate.

What phase is EDP-323 Dose Regimen 1 in?

EDP-323 Dose Regimen 1 has completed a Phase 2a clinical trial. It is an investigational agent and has not been approved by the FDA or any other regulatory authority for the treatment of RSV infection.

What clinical trials is EDP-323 Dose Regimen 1 in?

EDP-323 Dose Regimen 1 was evaluated in a single completed Phase 2a trial, NCT06170242, titled a controlled Phase 2a study to evaluate the efficacy of EDP-323 against respiratory syncytial virus infection in a virus challenge model. The trial enrolled 142 participants in the United Kingdom.

How was the EDP-323 Dose Regimen 1 Phase 2a trial designed?

NCT06170242 was a randomized, double-blind, placebo-controlled Phase 2a human viral challenge study. It enrolled 142 healthy adult volunteers aged 18 years and older of all sexes in the United Kingdom, and the trial has been completed.