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

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Pfizer

Status and phase

Terminated
Phase 1

Conditions

Healthy
Hypercholesterolemia

Treatments

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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