A Study To Assess The Safety Of PF-05335810 In Hypercholesterolemic Subjects

Summary

This study is to evaluate the safety, tolerability and immunogenicity of single, ascending or multiple fixed subcutaneous and intravenous administrations of PF 05335810 to hypercholesterolemic subjects when added on to a daily statin dose.

Conditions

• Hypercholesterolemia

Interventions

BIOLOGICAL

PF-05335810 Dose A

Single SC Injection

BIOLOGICAL

PF-05335810 Dose B

Single Subcutaneous Injection(s)

BIOLOGICAL

Placebo

Single Subcutaneous Injection(s)

BIOLOGICAL

PF-05335810 Dose B

Single Intravenous Infusion

BIOLOGICAL

Placebo

Single Intravenous Infusion

BIOLOGICAL

PF-04950615 Dose A

Single Subcutaneous Injection(s)

BIOLOGICAL

PF-04950615 Dose A

Single Intravenous Infusion

BIOLOGICAL

PF-05335810 Dose C

Single Subcutaneous Injection(s)

BIOLOGICAL

Placebo

Single Subcutaneous Injection(s)

BIOLOGICAL

PF-05335810 Dose C

Single Intravenous Infusion

BIOLOGICAL

Placebo

Single Intravenous Infusion

BIOLOGICAL

PF-04950615

Single Subcutaneous Injection(s)

BIOLOGICAL

PF-05335810 Dose D

Single Subcutaneous Injection(s)

BIOLOGICAL

Placebo

Single Subcutaneous Injection(s)

BIOLOGICAL

PF-05335810 Dose E

Multiple fixed dosages administered in subcutaneous injections, monthly for 3 months.

BIOLOGICAL

PF-05335810 Dose D

Single Intravenous Infusion

BIOLOGICAL

Placebo

Single Intravenous Infusion

Sponsors & Collaborators

• Pfizer

  lead INDUSTRY

Principal Investigators

• Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-07-31

Primary Completion

2013-10-31

Completion

2013-10-31

Countries

• United States

Study Locations