A Study To Access The Safety And Tolerability Of RN316 (PF-04950615) When Administered To Healthy Adult Subjects

Completed · Phase 1

Conditions studied: Healthy

In brief

The study is designed to determine the safety and tolerability of RN316 when administered intravenously to healthy adult subjects. This is the first time RN316 has been given to humans.

Key facts

Study ID

NCT00991159

Run by

Pfizer

People needed

48

Starts

2009-11-01

Expected to finish

2010-05-01

Last updated by the study team

2012-07-04

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy, ambulatory men and women (of non-childbearing potential) ages 18 -70 inclusive.
• Baseline total cholesterol ≥ 200 mg/dl, baseline LDL ≥ 130 mg/dl.
• BMI 18.5 to 35, and body weight ≤150 kg, inclusive.

You may not qualify if…

• Evidence of clinically significant disease that may increase the risk to the subject of study participation or interfere with interpretation of results.
• Secondary hyperlipidemia.
• Subjects who have taken lipid lowering compounds within the past 12 months prior to dosing.

Where it is running

• Pfizer Investigational Site — Phoenix, Arizona, United States
• Pfizer Investigational Site — Miami Gardens, Florida, United States

Full record on ClinicalTrials.gov

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