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PF-06730512

Phase 2

Undisclosed | Monoclonal antibody | Other |Pfizer, Inc.|Trials Updated: May 22, 2018

PF-06730512 development status

Highest phase Phase 2 (NCT03448692)
Phase scored for PFEPhase 1
Registered trials 2 across 1 sponsor since May 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment79

FDA Designations

No designations recorded

PF-06730512 clinical trials

PF-06730512 · 1 trial · 1 indication

Phase 1 1
NCT03146065Evaluation Of Safety, Tolerability And Pharmacokinetics Of Single And Multiple Doses Of PF-06730512Healthy
COMPLETED79 Analytics
PHASE1COMPLETED
Evaluation Of Safety, Tolerability And Pharmacokinetics Of Single And Multiple Doses Of PF-06730512
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Study Endpoints

Primary Endpoints

Number of Subjects With Treatment Emergent Treatment-Related Adverse Event(s)
Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)
Number of subjects with injection site reaction(s)
Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)
Number of subjects with laboratory test findings of potential clinical importance
Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)
Number of subjects with vital signs findings of potential clinical importance
Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)
Number of subjects with ECG findings of potential clinical importance
Dosing through approximately Day 71 (single dose) or Day 113 (multiple dose)

Secondary Endpoints

Maximum Observed Plasma Concentration (Cmax) of PF-06730512
Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)
Time to Reach Maximum Observed Concentration (Tmax) of PF-06730512
Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-06730512
Day 1 to approximately Day 71 (single dose) or Day 113 (multiple dose)
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
PF-06730512EXPERIMENTALStudy Drug being used in the study
PlaceboPLACEBO_COMPARATORPlacebo for IV/SC administration

Interventions

NameTypeDescription
PF-06730512BIOLOGICALComparison of different dosages of PF-06730512 to Placebo
PlaceboDRUGComparison of Placebo to different doses of PF-06730512
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy female subjects of nonchildbearing potential and/or male subjects who, at the time of screening, are between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical exami...

Countries:Belgium
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Frequently asked questions about PF-06730512

What is PF-06730512?

PF-06730512 is an investigational monoclonal antibody developed by Pfizer. It has been studied in a Phase 1 clinical trial evaluating its safety, tolerability, and pharmacokinetics in healthy adult volunteers. The specific disease indications for which it is being developed have not been publicly disclosed.

Who makes PF-06730512?

PF-06730512 is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker symbol PFE. Pfizer sponsored the Phase 1 clinical trial of the compound conducted in Belgium.

What phase is PF-06730512 in?

PF-06730512 is in Phase 1 clinical development. It is an investigational monoclonal antibody and has not been approved by the FDA. The single Phase 1 trial evaluating the drug has been completed.

What clinical trials is PF-06730512 in?

PF-06730512 has been evaluated in one clinical trial, NCT03146065, titled Evaluation Of Safety, Tolerability And Pharmacokinetics Of Single And Multiple Doses Of PF-06730512. The Phase 1 trial enrolled 79 healthy adult volunteers in Belgium and has been completed.

What was the design of the PF-06730512 Phase 1 trial?

The Phase 1 trial NCT03146065 was a randomized, double-blind, placebo-controlled study of single and multiple doses of PF-06730512. It enrolled 79 healthy volunteers of all sexes, aged 18 years and older, in Belgium, and evaluated safety, tolerability, and pharmacokinetics.