Safety and Tolerability of Single and Multiple Doses of ISIS 353512 in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

103

Participants

Timeline

Start Date

July 31, 2008

Primary Completion Date

February 28, 2010

Study Completion Date

March 31, 2010

Conditions
Inflammatory Diseases
Interventions
DRUG

ISIS 353512

50 mg via 2 hour IV infusion, single dose

DRUG

ISIS 353512

50 mg via 2 hour IV infusion, 6 doses over 22 days

DRUG

ISIS 353512

50 mg via SC injection, single dose

DRUG

ISIS 353512

50 mg via SC injection, 6 doses over 22 days

DRUG

ISIS 353512

2 hour IV infusion, 50 mg on day 3, 100 mg on day 5, and 200 mg on day 8

DRUG

ISIS 353512

100 mg via 2 hour IV infusion, single dose

DRUG

ISIS 353512

200 mg via 2 hour IV infusion, single dose

DRUG

ISIS 353512

100 mg via SC injection, single dose

DRUG

ISIS 353512

200 mg via SC injection, single-dose

DRUG

ISIS 353512

100 mg via 2 hour IV infusion, 6 doses over 22 days

DRUG

ISIS 353512

200 mg via 2 hour IV infusion, 6 doses over 22 days

DRUG

ISIS 353512

100 mg via SC injection, 6 doses over 22 days

DRUG

ISIS 353512

200 mg via SC injection, 6 doses over 22 days

DRUG

ISIS 353512

100 mg via SC injection PLUS an oral treatment of a NSAID, acetaminophen, or oral placebo

DRUG

ISIS 353512

200 mg via SC injection PLUS an oral treatment of a NSAID, acetaminophen, or steroid

DRUG

ISIS 353512

2 hour IV infusion, 50 mg on day 1, 100 mg on day 3, 100 mg on day 5 and 200mg on day 8

Trial Locations (1)

H3X 2H9

Anapharm, Montreal

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Anapharm

INDUSTRY

lead

Ionis Pharmaceuticals, Inc.

INDUSTRY