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
  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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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 ] [ Designated as safety issue: Yes ]

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 ] [ 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 ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00991159     History of Changes
Other Study ID Numbers: B1481001, RN316-101
Study First Received: October 5, 2009
Last Updated: July 2, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 28, 2014