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PF-05230905

Phase 1

Healthy | Small molecule | Other |Sanofi|Last Updated: Jan 31, 2013

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
Double-BlindUNCONTROLLED
Total Trials1
Total Enrollment63
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01284036A Single Dose Study Of The Safety And Investigational Product Level Measurement In Healthy SubjectsPHASE1 COMPLETED 63 — — Oct 1, 2010Nov 1, 2011Jan 31, 20131 United States
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Study Endpoints
Primary Endpoints
Safety endpoints will be evaluated by comparing reported adverse events in subjects receiving PF-05230905 versus subjects receiving placebo.
day 168
Incidence and severity of clinical laboratories including absolute hepatic transaminases and bilirubin levels will be evaluated.
day 168
Mean change from baseline in vital signs measurements. Mean change from baseline in 12 lead echocardiogram (ECG) will be compared to ensure safety of the subjects.
day 168
Secondary Endpoints
Incidence of development of Anti Drug Antibody.
day 168
Serum PF-05230905 concentrations will be determined by a validated assay, and noncompartmental pharmacokinetics (PK) parameters.
day 168
Urine pharmacokinetics (PK) parameters amount excreted in urine (Ae) and renal clearance will be determined.
day 168
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Study Design & Arms
AllocationNA
MaskingTRIPLE
ModelSINGLE_GROUP
Treatment Arms
ArmTypeDescription
PF-05230905OTHER9 subjects will participate in each dose cohort. 6 subjects will receive investigational product (PF-05230905) and 3 subjects will receive placebo
Interventions
NameTypeDescription
PF-05230905DRUGSingle dose subcutaneous or intravenous (IV) administration of PF-05230905 or placebo
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and/or female subjects between the ages of 18 and 55 years. * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). Exclusion Criteria: * Treatment with an investigational drug within 30 days (or as determined by the local requi...

Countries:United States
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