NCT02667223

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

A Phase 1, Open Label, Randomized, Single Dose, Dose Escalation Study To Assess The Subcutaneous Pharmacokinetics And Pharmacodynamics Of Bococizumab (pf 04950615) Alone And In Co Mixture With Recombinant Human Hyaluronidase (rhuph20, Pf 06744547) In Healthy And Hypercholesterolemic Adult Subjects

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy
• Hypercholesterolemia

Interventions

Type	Name	Description
BIOLOGICAL	Cohort 1: bococizumab 150 mg + rHuPH20	bococizumab 150 mg + rHuPH20 administered SC to healthy volunteers
BIOLOGICAL	Cohort 2: bococizumab 300 mg	bococizumab 300 mg administered SC to healthy volunteers
BIOLOGICAL	Cohort 3: bococizumab 300 mg + rHuPH20	bococizumab 300 mg + rHuPH20 administered SC to healthy volunteers
BIOLOGICAL	Cohort 5: bococizumab 450 mg + rHuPH20	bococizumab 450 mg + rHuPH20 administered SC to healthy volunteers
BIOLOGICAL	Cohort 4: bococizumab 300 mg + rHuPH20	bococizumab 300 mg + rHuPH20 administered SC to subjects with hypercholesterolemia receiving a statin

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2016-01-28
• Last updated: 2016-10-21

Locations

1 site across 1 country: Belgium