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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Hypercholesterolemia

Treatments: Biological: PF-05335810 Dose B; Biological: PF-05335810 Dose D; Biological: PF-04950615; Biological: Placebo; Biological: PF-05335810 Dose E; Biological: PF-04950615 Dose A; Biological: PF-05335810 Dose C; Biological: PF-05335810 Dose A

Study type: Interventional

Funder types: Industry

Identifiers

NCT01720537

B3091001

Details and patient eligibility

About

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.

Enrollment: 133 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• On stable daily doses of a statin for 45 days prior to receiving study treatment.
• Fasting LDL C equal or greater than 80 mg/dL at screening and visit approximately 1 week prior to randomization.

Exclusion criteria

• History of a cardiovascular or cerebrovascular event or procedure within one year of randomization.
• Poorly controlled type 1 or type 2 diabetes mellitus (defined as HbA1c >9%).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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133 participants in 6 patient groups

Cohort 1

Experimental group

Treatment:

Biological: PF-05335810 Dose A

Cohort 2

Experimental group

Treatment:

Biological: Placebo

Biological: PF-04950615 Dose A

Biological: PF-05335810 Dose B

Biological: PF-04950615 Dose A

Biological: PF-05335810 Dose B

Biological: Placebo

Biological: Placebo

Biological: Placebo

Biological: Placebo

Biological: Placebo

Cohort 3

Experimental group

Treatment:

Biological: Placebo

Biological: PF-05335810 Dose C

Biological: PF-05335810 Dose C

Biological: Placebo

Biological: Placebo

Biological: Placebo

Biological: PF-04950615

Biological: Placebo

Biological: Placebo

Cohort 4

Experimental group

Treatment:

Biological: Placebo

Biological: PF-05335810 Dose D

Biological: PF-05335810 Dose D

Biological: Placebo

Biological: Placebo

Biological: Placebo

Biological: Placebo

Biological: Placebo

Cohort 5

Experimental group

Treatment:

Biological: PF-05335810 Dose E

Cohort 6

Experimental group

Treatment:

Biological: Placebo

Biological: PF-05335810 Dose D

Biological: PF-05335810 Dose D

Biological: Placebo

Biological: Placebo

Biological: Placebo

Biological: Placebo

Biological: Placebo