A Phase 2a Study to Evaluate EDP-938 in the Virus Challenge Model

Enanta Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: RSV Infection

Treatments: Drug: Placebo; Drug: EDP-938 Dose 2; Drug: EDP-938 Dose 4; Drug: EDP-938 Dose 1; Drug: EDP-938 Dose 3

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT03691623

EDP 938-101

Details and patient eligibility

About

A randomised, Phase 2a, double-blind, placebo-controlled study to evaluate the safety, pharmacokinetics and antiviral activity of multiple doses of orally administered EDP-938 in healthy subjects infected with RSV-A Memphis 37b. This study is designed to compare the antiviral effect of EDP-938 compared to a placebo control in the respiratory syncytial virus challenge model.

Enrollment: 179 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/m^2 and ≤ 30kg/m^2

Exclusion criteria

• Pregnant or nursing females
• Acute or chronic medical illness
• Abnormal lung function
• Positive for human immunodeficiency virus (HIV), active hepatitis A, 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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179 participants in 6 patient groups, including a placebo group

EDP-938 Arm A

Experimental group

Description:

Subjects will take EDP-938 Dose 1 oral suspension for 5 days

Treatment:

Drug: EDP-938 Dose 1

EDP-938 Arm B

Experimental group

Description:

Subjects will take EDP-938 Dose 2 oral suspension for 5 days

Treatment:

Drug: EDP-938 Dose 2

Placebo Arm C

Placebo Comparator group

Description:

Subjects will take matching placebo oral suspension for 5 days

Treatment:

Drug: Placebo

EDP-938 Arm D

Experimental group

Description:

Subjects will take EDP-938 Dose 3 oral suspension for 5 days

Treatment:

Drug: EDP-938 Dose 3

EDP-938 Arm E

Experimental group

Description:

Subjects will take EDP-938 Dose 4 oral suspension for 5 days

Treatment:

Drug: EDP-938 Dose 4

Placebo Arm F

Placebo Comparator group

Description:

Subjects will take matching placebo oral suspension for 5 days

Treatment:

Drug: Placebo