NCT00231569

Dose-escalating Safety Study in Subjects on Stable Statin Therapy

A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Assess the Safety and Pharmacodynamics of ISIS 301012 in Hypercholesterolemic Subjects on Stable Statin Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Kastle Therapeutics, LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to assess the safety of varying doses of ISIS 301012 in subjects on Stable statin therapy.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	ISIS 301012 or Placebo	30 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
DRUG	ISIS 301012 or Placebo	100 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
DRUG	ISIS 301012 or Placebo	200 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
DRUG	ISIS 301012 or Placebo	300 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
DRUG	ISIS 301012 or Placebo	400 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, and 29
DRUG	ISIS 301012 or Placebo	200 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85
DRUG	ISIS 301012 or Placebo	300 mg subcutaneous injection on days 1, 8, 10, 12, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, and 85

Timeline

• Start date: 2005-09-01
• Primary completion: 2007-06-01
• Completion: 2007-12-01
• First posted: 2005-10-04
• Last updated: 2016-08-03

Locations

5 sites across 2 countries: United States, Netherlands