Pharmacokinetic and Pharmacodynamic Study of Bococizumab Alone and When Combined With Recombinant Human Hyaluronidase

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-07-31

Brief Summary

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This is a Phase 1, open-label, single-dose, randomized, dose escalation study in healthy and hypercholesterolemic subjects. Each subject will receive 1 of 5 treatments as a single subcutaneous injection. Subjects will remain confined at the research clinic for approximately 2 days. After discharge, subjects will return to the research clinic 15 times during 12 weeks.

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Detailed Description

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Conditions

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Healthy Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Cohort 1: bococizumab 150 mg + rHuPH20

bococizumab 150 mg co-mixed with rHuPH20 and administered subcutaneously to healthy volunteers

Group Type EXPERIMENTAL

Cohort 1: bococizumab 150 mg + rHuPH20

Intervention Type BIOLOGICAL

bococizumab 150 mg + rHuPH20 administered SC to healthy volunteers

Cohort 2: bococizumab 300 mg

bococizumab 300 mg administered subcutaneously to healthy volunteers

Group Type ACTIVE_COMPARATOR

Cohort 2: bococizumab 300 mg

Intervention Type BIOLOGICAL

bococizumab 300 mg administered SC to healthy volunteers

Cohort 3: bococizumab 300 mg + rHuPH20

bococizumab 300 mg co-mixed with rHuPH20 and administered subcutaneously to healthy volunteers

Group Type EXPERIMENTAL

Cohort 3: bococizumab 300 mg + rHuPH20

Intervention Type BIOLOGICAL

bococizumab 300 mg + rHuPH20 administered SC to healthy volunteers

Cohort 5: bococizumab 450 mg + rHUPH20

bococizumab 450 mg co-mixed with rHuPH20 and administered subcutaneously to healthy volunteers

Group Type EXPERIMENTAL

Cohort 5: bococizumab 450 mg + rHuPH20

Intervention Type BIOLOGICAL

bococizumab 450 mg + rHuPH20 administered SC to healthy volunteers

Cohort 4: bococizumab 300 mg + rHuPH20

bococizumab 300 mg co-mixed with rHuPH20 and administered subcutaneously to subjects with hypercholesterolemia receiving a statin

Group Type EXPERIMENTAL

Cohort 4: bococizumab 300 mg + rHuPH20

Intervention Type BIOLOGICAL

bococizumab 300 mg + rHuPH20 administered SC to subjects with hypercholesterolemia receiving a statin

Interventions

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Cohort 1: bococizumab 150 mg + rHuPH20

bococizumab 150 mg + rHuPH20 administered SC to healthy volunteers

Intervention Type BIOLOGICAL

Cohort 2: bococizumab 300 mg

bococizumab 300 mg administered SC to healthy volunteers

Intervention Type BIOLOGICAL

Cohort 3: bococizumab 300 mg + rHuPH20

bococizumab 300 mg + rHuPH20 administered SC to healthy volunteers

Intervention Type BIOLOGICAL

Cohort 5: bococizumab 450 mg + rHuPH20

bococizumab 450 mg + rHuPH20 administered SC to healthy volunteers

Intervention Type BIOLOGICAL

Cohort 4: bococizumab 300 mg + rHuPH20

bococizumab 300 mg + rHuPH20 administered SC to subjects with hypercholesterolemia receiving a statin

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Healthy and hypercholesterolemic subjects between the ages of 18 and 65 years.
* Healthy subjects must have fasting LDL-C \>/= 70 to \</= 190 mg/dL at two qualifying visits.
* Hypercholesterolemic subjects must be on a stable daily dose of statin for at least 45 days before dosing and fasting LDL-C must be \>/= 70 mg/dL.

Exclusion Criteria

* Use of prescription or non-prescription drugs within 7 days or 5 half-lives (whichever) is longer prior to the first dose of study medication. For hypercholesterolemic subjects the use of statin class medication is allowed.
* Prior exposure to bococizumab (also known as PF-04950615 or RN316) or other investigational PCSK9 inhibitors.
* Treatment with monoclonal antibodies within 6 months or 5 half-lives (whichever is longer) before dosing.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes