Healthy
Conditions
Keywords
Endocrinology; Hypercholesterolemia; Hyperlipidemia; Lipid Metabolism Disorders RN316 PF-04950615
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.
Interventions
BIOLOGICALRN316
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.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of single, escalating, intravenous infusions of RN316 administered to healthy adult subjects | Entire duration of study |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed