NCT01163838

Multiple-Dose Safety Study Of RN316 For TheTreatment Of Hypercholesterolemia

A Phase 1, Placebo-Controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Multiple Intravenous Doses Of RN316 In Healthy Adult Subjects With Hypercholesterolemia

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to evaluate the safety and tolerability of repeated doses of RN316 in eligible healthy volunteers. RN316 is an investigational drug that is currently being studied as a cholesterol lowering therapy.

Conditions

• Hypercholesterolemia
• Dyslipidemia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2010-08-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2010-07-16
• Last updated: 2015-04-23