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PF-06252616

Phase 1

Healthy | Monoclonal antibody | Other |Pfizer, Inc.|Last Updated: Sep 25, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment86

FDA Designations

No designations recorded

Clinical trial landscape

PF-06252616 · 1 trial · 1 indication

Phase 1 1
NCT01616277A Phase 1 Study To Evaluate The Safety And Tolerability Of PF-06252616 In Healthy SubjectsHealthy
COMPLETED86 Analytics
PHASE1COMPLETED
A Phase 1 Study To Evaluate The Safety And Tolerability Of PF-06252616 In Healthy Subjects
Healthy
NCT0161627786
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Study Endpoints

Primary Endpoints

Incidence of treatment related Adverse Events.
Day 197
Severity of treatment related Adverse Events.
Day 197
Incidence of abnormal lab findings.
Day 197
Magnitude of abnormal lab findings.
Day 197
Abnormal and clinically relevant changes in Blood Pressure.
Day 197
Abnormal and clinically relevant changes in Pulse Rate.
Day 197
Abnormal and clinically relevant changes in Respiratory Rate.
Day 197
Abnormal and clinically relevant changes in temperature.
Day 197
Abnormal and clinically relevant changes in ECG parameters.
Day 197

Secondary Endpoints

PF-06252616 concentration in serum as measured by a validated PK assay for Cmax (maximum concentration)
Through Day 197 post dosing
Pharmacodynamic activity as measured by serum concentrations of GDF-8 (myostatin) as measured by a GDF-8 assay
Through Day 197 post dosing
Incidence of development of anti-drug antibody (ADA) as measured by an ADA assay
Through Day 197 post dosing
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
1PLACEBO_COMPARATOR -
2PLACEBO_COMPARATOR -
3PLACEBO_COMPARATOR -
4PLACEBO_COMPARATOR -
5PLACEBO_COMPARATORRepeat dose of PF-06252616, IV infusion, single dose - 10.0 miligram per kilogram
6PLACEBO_COMPARATOR -
7PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
PF-06252616BIOLOGICAL1.0 milligram per kilogram of PF-06252616, IV infusion, single dose
PlaceboDRUGPlacebo for PF-06252616, IV infusion, single dose
PF-06252161BIOLOGICAL10.0 milligram per kilogram of PF-06252616, IV infusion, single dose
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Eligibility Criteria

Age Range18 Years to 64 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Single Dose Cohorts-Healthy male and/or female non-child bearing subjects between the ages of 18 and 55 years, inclusive. * Repeat Dose Cohort-Healthy male and/or female non-child bearing subjects between the ages of 18 and less than 65 years, inclusive. Exclusion Criteria: ...

Countries:United States
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Frequently asked questions about PF-06252616

What is PF 06252616?

PF 06252616 is an investigational small molecule being developed by Pfizer, Inc. (PFE). It has been studied in Phase 1 clinical trials for the treatment of LGMD2I, a form of limb-girdle muscular dystrophy, as well as in healthy volunteers. The drug is not approved and remains in clinical development.

What is PF 06252616 used for?

PF 06252616 is being investigated for use in LGMD2I, a genetic muscle disorder, and has also been studied in healthy subjects to evaluate its safety and tolerability. It is an investigational drug and has not been approved for any indication.

Who makes PF 06252616?

PF 06252616 is developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The company has conducted clinical trials to evaluate the drug's safety and tolerability.

What phase is PF 06252616 in?

PF 06252616 is in Phase 1 clinical development. Two Phase 1 trials have been completed, one in healthy subjects and one in participants with LGMD2I. The drug is investigational and has not received FDA approval.

What clinical trials is PF 06252616 in?

PF 06252616 has been studied in two completed Phase 1 trials: NCT01616277, which evaluated safety and tolerability in healthy subjects, and NCT02841267, which assessed the drug in ambulatory participants with LGMD2I. Both trials were conducted in the United States.

Is PF 06252616 the same as PF-06252616?

Yes, PF 06252616 and PF-06252616 refer to the same investigational drug developed by Pfizer. The hyphenated version is the standard naming format used in clinical trial registries and scientific literature.