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EDP-322

Phase 1

MRSA, SSTI | Small molecule | Infectious Disease |Enanta Pharmaceuticals, Inc.|Last Updated: Oct 8, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment52

FDA Designations

No designations recorded

Clinical trial landscape

EDP-322 · 2 trials · 3 indications

Phase 1 2
NCT00990145Multiple Ascending-Dose Study of EDP 322 in Healthy Adult VolunteersMRSA, SSTI
COMPLETED52 Analytics
NCT00989872Safety and Pharmacokinetics of Ascending Single Oral Doses of EDP-322 in Nonfasting and Fasting Healthy VolunteersSkin and Soft Tissue Infections
COMPLETED67 Analytics
PHASE1COMPLETED
Multiple Ascending-Dose Study of EDP 322 in Healthy Adult Volunteers
MRSA, SSTIUnlock trial analytics
PHASE1COMPLETED
Safety and Pharmacokinetics of Ascending Single Oral Doses of EDP-322 in Nonfasting and Fasting Healthy Volunteers
Skin and Soft Tissue InfectionsUnlock trial analytics

Study Endpoints

Primary Endpoints

The study objective was to determine the safety, tolerability and pharmacokinetics of multiple oral doses of EDP-322 in healthy volunteers.
Subjects received single doses of the study drug administered QD on Days 1 through 7, with follow-up through Day 11, and as needed.
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

Treatment Arms

ArmTypeDescription
InterventionEXPERIMENTALEDP-322 v. Placebo

Interventions

NameTypeDescription
EDP-322DRUG -
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy adult males or females between 18 and 45 years of age * Females are eligible if documentation exists that they are surgically sterilized * In good general health \[determined by medical history, physical examination, clinical laboratory tests, and without evidence of a...

Countries:United States
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Frequently asked questions about EDP-322

What is EDP-322 used for?

EDP-322 is an investigational small molecule being developed for the treatment of skin and soft tissue infections (SSTI), including those caused by methicillin-resistant Staphylococcus aureus (MRSA). It is currently in Phase 1 clinical development and has not been approved by the FDA.

Who makes EDP-322?

EDP-322 is being developed by Enanta Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker ENTA. The drug is in Phase 1 clinical development for infectious disease indications.

What phase is EDP-322 in?

EDP-322 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Clinical trials have been completed in healthy volunteers to evaluate safety and pharmacokinetics.

What clinical trials has EDP-322 been in?

EDP-322 has been studied in two completed Phase 1 trials. NCT00989872 evaluated ascending single oral doses in healthy volunteers, and NCT00990145 was a multiple ascending-dose study. Both trials were conducted in the United States and enrolled healthy adults.

Is EDP-322 the same as EDP 322?

Yes, EDP-322 is also referred to as EDP 322 in clinical trial records. Both names refer to the same investigational small molecule being developed by Enanta Pharmaceuticals for skin and soft tissue infections, including MRSA.