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PF-05230907

Phase 1

Healthy | Monoclonal antibody | Other |Pfizer, Inc.|Last Updated: Apr 29, 2016

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-BlindCONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment66
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02537002Single Dose Study of PF-05230907 in Healthy Japanese SubjectsPHASE1 COMPLETED 17 — — Sep 1, 2015Mar 1, 2016Apr 29, 20161 United States
NCT01897142A Phase 1 Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-05230907 In Healthy VolunteersPHASE1 COMPLETED 49 — — Sep 1, 2013Mar 1, 2015Apr 22, 20161 Belgium
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Study Endpoints
Primary Endpoints
Incidence of Adverse Events and Serious Adverse Events Per Participant of PF-05230907
up to 2 months
Incidence of dose limiting treatment related adverse events
Through Day 43
Incidence, severity and causal relationship of treatment emergent adverse events, treatment emergent serious adverse events, and withdrawals due to treatment emergent adverse events
Through Day 43
Incidence and magnitude of treatment emergent abnormal laboratory findings
Through Day 43
Change from baseline in vital sign measurements, ECG parameters, and physical examinations
Through Day 43
Secondary Endpoints
Single dose Time to Reach maximum Observed Plasma Concentration (Tmax) of PF-05230907
Minute 0, 2, 5, 15, 40, 60 minute post-dose
Single dose Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)]of PF-05230907
Minute 0, 2, 5, 15, 40, 60 minute post-dose
Single dose Plasma Decay Half-Life (t1/2) of PF-05230907
Minute 0, 2, 5, 15, 40, 60 minute post-dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Cohort 1- PF-05230907 or PlaceboEXPERIMENTAL -
Cohort 2- PF-05230907 or PlaceboEXPERIMENTAL -
PF-05230907 and Placebo Cohort 1EXPERIMENTAL -
PF-05230907 and Placebo Cohort 2EXPERIMENTAL -
PF-05230907 and Placebo Cohort 3EXPERIMENTAL -
PF-05230907 and Placebo Cohort 4EXPERIMENTAL -
PF-05230907 and Placebo Cohort 5EXPERIMENTAL -
PF-05230907 and Placebo Cohort 6EXPERIMENTAL -
Interventions
NameTypeDescription
PF-05230907DRUGA single intravenous dose of 3 μg/kg
PlaceboDRUGA single intravenous dose of matched placebo
Placebo for PF-05230907DRUG0.1 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male of females * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs) and \<120 kg (265 lbs). * Japanese subjects who have four biologic Japanese grandparents born in Japan. Exclusion Criteria: * Pregnant or nursing females. * Femal...

Countries:United StatesBelgium
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