Safety And Tolerability Of Multiple Doses Of PF-04950615 (RN316) In Subjects With Hypercholesterolemia



Status:Completed
Conditions:High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 80
Updated:1/23/2019
Start Date:February 2011
End Date:October 2011

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A Phase 1, Placebo-controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Multiple Intravenous Doses Of Pf-04950615 In Healthy Adult Subjects With Hypercholesterolemia

The primary objective of this study is to evaluate the safety and tolerability of repeated
doses of PF-04950615 (RN316) in study volunteers with hypercholesterolemia. PF-04950615 is an
investigational drug that is currently being studied as a lipid lowering agent.


Inclusion Criteria:

- LDL-C must be greater or equal to 130 mg/dl

- BMI must be between 18.5 and 40 kg/m2

- Japanese volunteers must have 4 Japanese grand parents born in Japan

Exclusion Criteria:

- History of cardiovascular or cerebrovascular event during the past year.

- Poorly controlled type 1 or type 2 diabetes mellitus

- Subjects who have taken lipid lowering therapies within the last 3 months of
screening.
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Culver City, California 90232
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Glendale, California 91206
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Honolulu, Hawaii 96813
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Miami, Florida 33126
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Overland Park, Kansas 23112
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Saint Paul, Minnesota 55114
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