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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03691623
Recruitment Status : Completed
First Posted : October 2, 2018
Last Update Posted : January 14, 2020
Sponsor:
Collaborator:
hVIVO Services Limited
Information provided by (Responsible Party):
Enanta Pharmaceuticals

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
RSV Infection Drug: EDP-938 Dose 1 Drug: EDP-938 Dose 2 Drug: Placebo Drug: EDP-938 Dose 3 Drug: EDP-938 Dose 4 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 179 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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 Against Respiratory Syncytial Virus Infection in the Virus Challenge Model.
Actual Study Start Date : October 17, 2018
Actual Primary Completion Date : September 30, 2019
Actual Study Completion Date : October 18, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EDP-938 Arm A
Subjects will take EDP-938 Dose 1 oral suspension for 5 days
Drug: EDP-938 Dose 1
Oral suspension for 5 days

Experimental: EDP-938 Arm B
Subjects will take EDP-938 Dose 2 oral suspension for 5 days
Drug: EDP-938 Dose 2
Oral suspension for 5 days

Placebo Comparator: Placebo Arm C
Subjects will take matching placebo oral suspension for 5 days
Drug: Placebo
Oral suspension for 5 days

Experimental: EDP-938 Arm D
Subjects will take EDP-938 Dose 3 oral suspension for 5 days
Drug: EDP-938 Dose 3
Oral suspension for 5 days

Experimental: EDP-938 Arm E
Subjects will take EDP-938 Dose 4 oral suspension for 5 days
Drug: EDP-938 Dose 4
Oral suspension for 5 days

Placebo Comparator: Placebo Arm F
Subjects will take matching placebo oral suspension for 5 days
Drug: Placebo
Oral suspension for 5 days




Primary Outcome Measures :
  1. Change in viral load measurements [ Time Frame: Post initial dose of EDP-938 up to Day 12 ]
    Area under the curve for RSV viral load as measured by RT-qPCR assay from the first viral load measurement post initial dose of EDP-938 or placebo through day 12


Secondary Outcome Measures :
  1. Change of baseline symptoms [ Time Frame: Innoculation through Day 12 ]
    Change of baseline symptoms post initial dose of EDP-938 or placebo through Day 12



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 ≤ 30kg/m2

Exclusion Criteria:

  • Pregnant or nursing females
  • Acute or chronic medical illness
  • Abnormal lung function
  • Positive for 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03691623


Locations
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United Kingdom
hVIVO Services Limited (hVIVO)
London, United Kingdom
Sponsors and Collaborators
Enanta Pharmaceuticals
hVIVO Services Limited
Investigators
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Study Director: Enanta Pharmaceuticals, Inc Enanta Pharmaceuticals, Inc
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Responsible Party: Enanta Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03691623    
Other Study ID Numbers: EDP 938-101
First Posted: October 2, 2018    Key Record Dates
Last Update Posted: January 14, 2020
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Enanta Pharmaceuticals:
challenge study
RSV
antiviral
RSV-A Memphis 37b
Additional relevant MeSH terms:
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Infection
Respiratory Syncytial Virus Infections
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases