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

Enanta Pharmaceuticals logo

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

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

Trial documents
2

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location

Resources

© Copyright 2024 Veeva Systems