NCT00927459

Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Liposomal siRNA in Subjects With High Cholesterol

A Placebo-Controlled, Single-Blind, Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PRO-040201 in Male and Female Subjects With Hypercholesterolemia

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Arbutus Biopharma Corporation · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study is a Phase 1, single-center, placebo-controlled, single-blind, first-in-human, single-ascending dose study in male and female subjects with high cholesterol. A maximum of 32 subjects is planned for enrollment in this study.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	PRO-040201	Single dose IV infusion
DRUG	Placebo	placebo

Timeline

• Start date: 2009-06-01
• Primary completion: 2009-12-01
• Completion: 2010-01-01
• First posted: 2009-06-25
• Last updated: 2010-01-22

Locations

1 site across 1 country: United States