Single Dose Manufacturing Site (Pfizer vs. BIP) And Device (Prefilled Syringe vs. Prefilled Pen) Comparability Study For Bococizumab In Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

470

Participants

Timeline

Start Date

May 31, 2015

Primary Completion Date

December 31, 2015

Study Completion Date

December 31, 2015

Conditions
Healthy
Interventions
BIOLOGICAL

bococizumab PFS:Pfizer

150 mg bococizumab administered SC in a prefilled syringe using drug substance manufactured at Pfizer Andover

BIOLOGICAL

bococizumab PFS: BIP

150 mg bococizumab administered SC in a prefilled syringe using drug substance manufactured at Boehringer Ingelheim Pharma.

BIOLOGICAL

bococizumab PFP

150 mg bococizumab administered SC in a prefilled pen using drug substance manufactured at Pfizer Andover

Trial Locations (5)

27265

High Point Clinical Trials Center, LLC, High Point

33024

Broward Research Group, Hollywood

33143

Miami Research Associates, LLC, South Miami

MRA Clinical Research, LLC, South Miami

55114

Prism Research, LLC, Saint Paul

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY