Dose-escalating Safety Study in Subjects on Stable Statin Therapy

PHASE2CompletedINTERVENTIONAL
Enrollment

74

Participants

Timeline

Start Date

September 30, 2005

Primary Completion Date

June 30, 2007

Study Completion Date

December 31, 2007

Conditions
Hypercholesterolemia
Interventions
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

Trial Locations (5)

04210

Auburn

1105 AZ

Amsterdam

2311 GZ

Leiden

3021 HC

Rotterdam

3584 CX

Utrecht

Sponsors
All Listed Sponsors
collaborator

Ionis Pharmaceuticals, Inc.

INDUSTRY

lead

Kastle Therapeutics, LLC

INDUSTRY