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Completed

NCT Number: NCT00991159

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

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Key information

Conditions

Healthy Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RN316

Biological

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.

Primary outcomes

  1. Safety and tolerability of single, escalating, intravenous infusions of RN316 administered to healthy adult subjects

    Time frame: Entire duration of study

Secondary outcomes

  1. pharmacokinetics of RN316 in plasma after administration of single, escalating, intravenous infusions of RN316 to healthy adult subjects

    Time frame: Entire duration of study

  2. pharmacodynamic effect (lipid-lowering) of single, escalating, intravenous doses of RN316 administered to healthy adult subjects

    Time frame: Entire duration of study

  3. single dose immunogenicity

    Time frame: Entire duration of study

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 7, 2009
Registry last updated
Jul 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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