Status:
COMPLETED
A Study To Access The Safety And Tolerability Of RN316 (PF-04950615) When Administered To Healthy Adult Subjects
Lead Sponsor:
Pfizer
Conditions:
Healthy
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00991159
Start Date
November 1 2009
End Date
May 1 2010
Last Update
July 4 2012
Active Locations (2)
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1
Pfizer Investigational Site
Phoenix, Arizona, United States, 85013
2
Pfizer Investigational Site
Miami Gardens, Florida, United States, 33169