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BLI-489

Phase 1

Healthy Subjects | Small molecule | Other |Pfizer, Inc.|Last Updated: Jul 17, 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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials2
Total Enrollment78
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00894439Study Evaluating BLI-489 and Piperacillin in Healthy SubjectsPHASE1 COMPLETED 24May 1, 2009Jul 1, 2009Jul 17, 20091 United States
NCT00820404Study Evaluating Single Doses of BLI-489 in Healthy SubjectsPHASE1 COMPLETED 54Jan 1, 2009Apr 1, 2009Jul 17, 20091 United States
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Study Endpoints
Primary Endpoints
Pharmacokinetics as evaluated by drug concentrations in the blood and urine.
10 days
Safety as measured by the number of adverse events and serious adverse events. Tolerability will be assessed based upon the occurrence of dose limiting toxicities.
15 days
Secondary Endpoints
Safety as measured by the number of adverse events and serious adverse events.
10 weeks
Pharmacokinetics as evaluated by drug concentrations in the blood and urine.
4 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2PLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
BLI-489/PiperacillinDRUG -
BLI-489DRUG -
PiperacillinDRUG -
PlaceboDRUG -
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Men or women of non-childbearing potential, aged 18 to 50 years of age inclusive at screening. 2. Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight greater than or equal to 50 kg. 3. Healthy as determined by the investigator on the basis of the screening ev...

Countries:United States
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