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EDP-322

Phase 1

Skin and Soft Tissue Infections | Small molecule | Dermatology |Enanta Pharmaceuticals, Inc.|Last Updated: Oct 6, 2009

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment67
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00989872Safety and Pharmacokinetics of Ascending Single Oral Doses of EDP-322 in Nonfasting and Fasting Healthy VolunteersPHASE1 COMPLETED 67 - -Oct 6, 20091 United States
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Study Endpoints
Primary Endpoints
The study objectives included determining the safety, tolerability and pharmacokinetics of single oral doses of EDP-322 in healthy adult volunteers
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
PurposeTREATMENT
Interventions
NameTypeDescription
EDP-322DRUG -
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy adult males or females \[if documentation existed that they were surgically sterilized\]. * Were in good general health as determined by medical history, physical exam and clinical laboratory tests, and without evidence of clinically significant abnormality, in the opi...

Countries:United States
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