A Study To Access The Safety And Tolerability Of RN316 (PF-04950615) When Administered To Healthy Adult Subjects
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Biological: RN316
- Registration Number
- NCT00991159
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description RN316 RN316 -
- Primary Outcome Measures
Name Time Method Safety and tolerability of single, escalating, intravenous infusions of RN316 administered to healthy adult subjects Entire duration of study
- Secondary Outcome Measures
Name Time Method pharmacokinetics of RN316 in plasma after administration of single, escalating, intravenous infusions of RN316 to healthy adult subjects Entire duration of study pharmacodynamic effect (lipid-lowering) of single, escalating, intravenous doses of RN316 administered to healthy adult subjects Entire duration of study single dose immunogenicity Entire duration of study
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Miami Gardens, Florida, United States