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

Enanta Pharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: RSV Infection

Treatments: Drug: EDP-323 Dose Regimen 1; Drug: Placebo; Drug: EDP-323 Dose Regimen 2

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06170242

EDP 323-101

Details and patient eligibility

About

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.

Enrollment: 114 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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114 participants in 3 patient groups, including a placebo group

EDP-323 Arm A

Experimental group

Description:

Subjects will take EDP-323 Dose 1 orally for 5 days

Treatment:

Drug: EDP-323 Dose Regimen 1

EDP-323 Arm B

Experimental group

Description:

Subjects will take EDP-323 Dose 2 orally for 5 days

Treatment:

Drug: EDP-323 Dose Regimen 2

Placebo Arm C

Placebo Comparator group

Description:

Subjects will take matching placebo orally for 5 days

Treatment:

Drug: Placebo