Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00519727
Status:
COMPLETED
Last Update Posted:
2008-08-19
First Post:
2007-08-21
Brief Title:
Safety Study of ISIS 325568 in Healthy Volunteers
Sponsor:
Ionis Pharmaceuticals Inc
Organization:
Ionis Pharmaceuticals Inc
Study Overview
Official Title:
A Phase I Double-Blind Placebo-Controlled Dose- Escalation Study to Assess the Safety Tolerability Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of ISIS 325568 Administered to Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2008-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of this trial is to assess the safety of ISIS 325568 when given at increasing single doses and to assess the safety of the same doses when given multiple times
Detailed Description:
To evaluate the safety of a single subcutaneous injection of ISIS 325568 administered at four increasing dose levels 50 100 200 400 mgweek and to evaluate the safety and tolerability of multiple doses of ISIS 325568 three intravenous doses during Study Week 1 followed by once weekly subcutaneous administration for 5 weeks at each of the four dose levels
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT No 2007-000235-25 | None | None | None |