A Phase 2a Study to Evaluate EDP-938 in the Virus Challenge Model
NCT ID: NCT03691623
Last Updated: 2022-05-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
179 participants
INTERVENTIONAL
2018-10-15
2019-10-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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EDP-938 Arm A
Subjects will take EDP-938 Dose 1 oral suspension for 5 days
EDP-938 Dose 1
Oral suspension for 5 days
EDP-938 Arm B
Subjects will take EDP-938 Dose 2 oral suspension for 5 days
EDP-938 Dose 2
Oral suspension for 5 days
Placebo Arm C
Subjects will take matching placebo oral suspension for 5 days
Placebo
Oral suspension for 5 days
EDP-938 Arm D
Subjects will take EDP-938 Dose 3 oral suspension for 5 days
EDP-938 Dose 3
Oral suspension for 5 days
EDP-938 Arm E
Subjects will take EDP-938 Dose 4 oral suspension for 5 days
EDP-938 Dose 4
Oral suspension for 5 days
Placebo Arm F
Subjects will take matching placebo oral suspension for 5 days
Placebo
Oral suspension for 5 days
Interventions
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EDP-938 Dose 1
Oral suspension for 5 days
EDP-938 Dose 2
Oral suspension for 5 days
Placebo
Oral suspension for 5 days
EDP-938 Dose 3
Oral suspension for 5 days
EDP-938 Dose 4
Oral suspension for 5 days
Placebo
Oral suspension for 5 days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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hVIVO Services Limited
INDUSTRY
Enanta Pharmaceuticals, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Enanta Pharmaceuticals, Inc
Role: STUDY_DIRECTOR
Enanta Pharmaceuticals, Inc
Locations
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hVIVO Services Limited (hVIVO)
London, , United Kingdom
Countries
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References
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Levene RE, DeVincenzo J, Conery AL, Ahmad A, Or YS, Rhodin MHJ. EDP-938 Has a High Barrier to Resistance in Healthy Adults Experimentally Infected with Respiratory Syncytial Virus. J Infect Dis. 2025 Feb 20;231(2):e290-e298. doi: 10.1093/infdis/jiae471.
Ahmad A, Eze K, Noulin N, Horvathova V, Murray B, Baillet M, Grey L, Mori J, Adda N. EDP-938, a Respiratory Syncytial Virus Inhibitor, in a Human Virus Challenge. N Engl J Med. 2022 Feb 17;386(7):655-666. doi: 10.1056/NEJMoa2108903.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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EDP 938-101
Identifier Type: -
Identifier Source: org_study_id
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