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PF-06730512

Phase 1

Healthy | Monoclonal antibody | Other |Pfizer, Inc.|Last Updated: May 22, 2018

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

Clinical trial landscape

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
Healthy
NCT0314606579
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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 being developed by Pfizer, Inc. It is currently in Phase 1 clinical development. The drug has been studied in healthy volunteers to evaluate its safety, tolerability, and pharmacokinetics. It is not approved by the FDA and remains in clinical trials.

What is PF-06730512 used for?

PF-06730512 is being studied for use in healthy volunteers, as part of early-phase clinical trials. The completed Phase 1 trial assessed the safety, tolerability, and pharmacokinetics of single and multiple doses of the drug. Its intended therapeutic indication has not been established, as it is still in early clinical development.

Who makes PF-06730512?

PF-06730512 is developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is an investigational monoclonal antibody currently in Phase 1 clinical development.

What phase is PF-06730512 in?

PF-06730512 is in Phase 1 clinical development. A Phase 1 trial (NCT03146065) has been completed, which evaluated the safety, tolerability, and pharmacokinetics of single and multiple doses of the drug in healthy volunteers. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is PF-06730512 in?

PF-06730512 has been studied in one completed Phase 1 clinical trial, identified as NCT03146065. This trial evaluated the safety, tolerability, and pharmacokinetics of single and multiple doses of PF-06730512 in 79 healthy volunteers in Belgium. The trial was randomized, double-blind, and placebo-controlled.