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

Pfizer

Status and phase: Terminated; Phase 1

Conditions: Healthy; Hypercholesterolemia

Treatments: Biological: Cohort 2: bococizumab 300 mg; Biological: Cohort 5: bococizumab 450 mg + rHuPH20; Biological: Cohort 1: bococizumab 150 mg + rHuPH20; Biological: Cohort 3: bococizumab 300 mg + rHuPH20; Biological: Cohort 4: bococizumab 300 mg + rHuPH20

Study type: Interventional

Funder types: Industry

Identifiers

NCT02667223

B1481051

2015-003568-36 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

60 participants in 5 patient groups

Cohort 1: bococizumab 150 mg + rHuPH20

Experimental group

Description:

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

Treatment:

Biological: Cohort 1: bococizumab 150 mg + rHuPH20

Cohort 2: bococizumab 300 mg

Active Comparator group

Description:

bococizumab 300 mg administered subcutaneously to healthy volunteers

Treatment:

Biological: Cohort 2: bococizumab 300 mg

Cohort 3: bococizumab 300 mg + rHuPH20

Experimental group

Description:

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

Treatment:

Biological: Cohort 3: bococizumab 300 mg + rHuPH20

Cohort 5: bococizumab 450 mg + rHUPH20

Experimental group

Description:

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

Treatment:

Biological: Cohort 5: bococizumab 450 mg + rHuPH20

Cohort 4: bococizumab 300 mg + rHuPH20

Experimental group

Description:

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

Treatment:

Biological: Cohort 4: bococizumab 300 mg + rHuPH20