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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:
ClinicalTrials.gov Identifier:
NCT00991159
First Posted: October 7, 2009
Last Update Posted: July 4, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose
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.

Condition Intervention Phase
Healthy Biological: RN316 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety and tolerability of single, escalating, intravenous infusions of RN316 administered to healthy adult subjects [ Time Frame: Entire duration of study ]

Secondary Outcome Measures:
  • pharmacokinetics of RN316 in plasma after administration of single, escalating, intravenous infusions of RN316 to healthy adult subjects [ Time Frame: Entire duration of study ]
  • pharmacodynamic effect (lipid-lowering) of single, escalating, intravenous doses of RN316 administered to healthy adult subjects [ Time Frame: Entire duration of study ]
  • single dose immunogenicity [ Time Frame: Entire duration of study ]

Enrollment: 48
Study Start Date: November 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RN316 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00991159


Locations
United States, Arizona
Pfizer Investigational Site
Phoenix, Arizona, United States, 85013
United States, Florida
Pfizer Investigational Site
Miami Gardens, Florida, United States, 33169
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00991159     History of Changes
Other Study ID Numbers: B1481001
RN316-101
First Submitted: October 5, 2009
First Posted: October 7, 2009
Last Update Posted: July 4, 2012
Last Verified: July 2012

Keywords provided by Pfizer:
Endocrinology; Hypercholesterolemia; Hyperlipidemia; Lipid Metabolism Disorders RN316 PF-04950615