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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Biological: RN316

Study type: Interventional

Funder types: Industry

Identifiers

NCT00991159

RN316-101

B1481001

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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48 participants in 1 patient group

RN316

Experimental group

Treatment:

Biological: RN316