Multiple-Dose Safety Study Of RN316 For TheTreatment Of Hypercholesterolemia

PHASE1WithdrawnINTERVENTIONAL
0
Timeline

Start Date

August 31, 2010

Primary Completion Date

March 31, 2011

Study Completion Date

March 31, 2011

Conditions
HypercholesterolemiaDyslipidemia
Interventions
BIOLOGICAL

Placebo

Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.

BIOLOGICAL

1 mg/kg every 2 weeks

Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.

BIOLOGICAL

2 mg/kg every 4 weeks

Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.

BIOLOGICAL

4 mg/kg every 4 weeks

Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.

BIOLOGICAL

4 mg/kg every 8 weeks

Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.

BIOLOGICAL

8 mg/kg every 8 weeks

Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.

BIOLOGICAL

12 mg/kg every 8 weeks

Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pfizer

INDUSTRY