Recent Updates
Recently added Catalysts

EDP-322

Phase 1

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

EDP-322 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Oct 2009

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment119

FDA Designations

No designations recorded

EDP-322 clinical trials

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
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE

Treatment Arms

ArmTypeDescription
InterventionEXPERIMENTALEDP-322 v. Placebo

Interventions

NameTypeDescription
EDP-322DRUG -
Unlock Study Design Details

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
Unlock Eligibility Criteria

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, including those caused by methicillin-resistant Staphylococcus aureus (MRSA). It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

What does EDP-322 target?

The specific molecular target of EDP-322 has not been disclosed in available information. It is being studied for its potential to treat skin and soft tissue infections, including MRSA, but its mechanism of action is not publicly detailed.

Who makes EDP-322?

EDP-322 is being developed by Enanta Pharmaceuticals, Inc., a biopharmaceutical company publicly traded under the ticker symbol ENTA. The company is conducting clinical trials to evaluate the safety and pharmacokinetics of the drug.

What phase is EDP-322 in?

EDP-322 is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving healthy volunteers. The drug is investigational and has not received FDA approval for any indication.

What clinical trials is EDP-322 in?

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