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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

September 28, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 2, 2018

Actual Study Start Date ^ICMJE

October 2018

Estimated Primary Completion Date

June 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Drug: EDP-938 Dose 1
Oral suspension for 5 days
Drug: EDP-938 Dose 2
Oral suspension for 5 days
Drug: Placebo
Oral suspension for 5 days

Study Arms

Experimental: EDP-938 Arm A
Subjects will take 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
Placebo Comparator: Placebo
Subjects will take matching placebo oral suspension for 5 days

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

114

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

June 2019

Estimated Primary Completion Date

June 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United Kingdom

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

Enanta Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director: Enanta Pharmaceuticals, Inc Enanta Pharmaceuticals, Inc

PRS Account

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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