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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00991159
First received: October 5, 2009
Last updated: July 2, 2012
Last verified: July 2012
History of Changes

October 5, 2009
July 2, 2012
November 2009
May 2010   (final data collection date for primary outcome measure)
Safety and tolerability of single, escalating, intravenous infusions of RN316 administered to healthy adult subjects [ Time Frame: Entire duration of study ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00991159 on ClinicalTrials.gov Archive Site
  • pharmacokinetics of RN316 in plasma after administration of single, escalating, intravenous infusions of RN316 to healthy adult subjects [ Time Frame: Entire duration of study ] [ Designated as safety issue: Yes ]
  • pharmacodynamic effect (lipid-lowering) of single, escalating, intravenous doses of RN316 administered to healthy adult subjects [ Time Frame: Entire duration of study ] [ Designated as safety issue: No ]
  • single dose immunogenicity [ Time Frame: Entire duration of study ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Study To Access The Safety And Tolerability Of RN316 (PF-04950615) When Administered To Healthy Adult Subjects
A Phase 1, Placebo-Controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Single, Escalating, Intravenous Doses Of RN316 (PF-04950615) In Healthy Adult Subjects

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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Healthy
Biological: RN316
Single, escalating doses of RN316 administered IV. Doses planned for testing = 0.3, 1.0, 3.0, 6.0, 12.0, and 18.0 mg/kg.
Experimental: RN316
Intervention: Biological: RN316
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
May 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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.
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00991159
B1481001, RN316-101
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP