The trial is taking place at:
H

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

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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

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

Trial contacts and locations

1

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Central trial contact

Enanta Pharmaceuticals, Inc

Data sourced from clinicaltrials.gov

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