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PF-05230907

Phase 1

Undisclosed | Monoclonal antibody | Other |Pfizer, Inc.|Trials Updated: Apr 29, 2016

PF-05230907 development status

Highest phase Phase 1
Registered trials 3 across 1 sponsor since Jul 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials2
Total Enrollment66

FDA Designations

No designations recorded

PF-05230907 clinical trials

PF-05230907 · 2 trials · 1 indication

Phase 1 2
NCT02537002Single Dose Study of PF-05230907 in Healthy Japanese SubjectsHealthy
COMPLETED17 Analytics
NCT01897142A Phase 1 Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-05230907 In Healthy VolunteersHealthy
COMPLETED49 Analytics
PHASE1COMPLETED
Single Dose Study of PF-05230907 in Healthy Japanese Subjects
HealthyUnlock trial analytics
PHASE1COMPLETED
A Phase 1 Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-05230907 In Healthy Volunteers
HealthyUnlock trial analytics

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 to 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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Frequently asked questions about PF-05230907

What is PF-05230907?

PF-05230907 is an investigational monoclonal antibody developed by Pfizer, Inc. It has been studied in Phase 1 clinical trials in healthy adult volunteers. The specific disease or condition it is intended to treat has not been disclosed, and no approved indication is associated with it.

Who makes PF-05230907?

PF-05230907 is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer sponsored both Phase 1 trials of the antibody, one conducted in the United States and one in Belgium.

What phase is PF-05230907 in?

PF-05230907 is in Phase 1 development. Both of its clinical trials were Phase 1 studies in healthy volunteers, and both have been completed. No later-phase trials have been registered, and the antibody is not approved for any indication.

What clinical trials is PF-05230907 in?

PF-05230907 has been evaluated in two completed Phase 1 trials. NCT01897142 tested safety, tolerability, pharmacokinetics and pharmacodynamics in 49 healthy volunteers in Belgium. NCT02537002 was a single-dose study in 17 healthy Japanese subjects in the United States. Together the trials enrolled 66 participants.

How was PF-05230907 studied in its clinical trials?

Both PF-05230907 trials were randomized, double-blind, and controlled, enrolling a total of 66 healthy adult volunteers aged 18 and older. NCT01897142 enrolled 49 participants in Belgium, and NCT02537002 enrolled 17 healthy Japanese subjects in the United States. Both studies are now completed.