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PF-05230907

Phase 1

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

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

Clinical trial landscape

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 being developed by Pfizer, Inc. (PFE). It is currently in Phase 1 clinical development and has been studied in healthy volunteers. The drug is not approved and remains in clinical testing.

What is PF-05230907 used for?

PF-05230907 has been studied in healthy volunteers in Phase 1 clinical trials. The studies evaluated its safety, tolerability, pharmacokinetics, and pharmacodynamics. The drug is investigational and has not been approved for any medical condition.

Who makes PF-05230907?

PF-05230907 is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is in Phase 1 clinical development.

What phase is PF-05230907 in?

PF-05230907 is in Phase 1 clinical development. Two Phase 1 studies have been completed, both involving healthy volunteers. The drug is investigational and has not received regulatory approval.

What clinical trials is PF-05230907 in?

PF-05230907 has been studied in two completed Phase 1 trials. NCT01897142 enrolled 49 healthy volunteers in Belgium, and NCT02537002 enrolled 17 healthy Japanese subjects in the United States. Both trials were single-dose studies.

Is PF-05230907 FDA approved?

PF-05230907 is not FDA approved. It is an investigational monoclonal antibody in Phase 1 clinical development. Two Phase 1 trials in healthy volunteers have been completed, but the drug has not been approved for any use.