Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00734240 | Safety and Tolerability of Single and Multiple Doses of ISIS 353512 in Healthy Volunteers | PHASE1 | COMPLETED | 103 | — | — | Jul 1, 2008 | Mar 1, 2010 | Jul 29, 2010 | 1 | Canada |
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | single-dose cohort (n=4, randomized 3 active : 1 placebo) receiving ISIS 355312 or placebo |
| B | EXPERIMENTAL | single-dose cohort (n=4, randomized 3 active : 1 placebo) receiving ISIS 353512 or placebo |
| C | EXPERIMENTAL | single-dose cohort (n=4, randomized 3 active : 1 placebo) receiving ISIS 353512 or placebo |
| AA | EXPERIMENTAL | multiple-dose cohort (n=4, randomized 3 active : 1 placebo) receiving 353512 or placebo |
| BB | EXPERIMENTAL | multiple-dose cohort (n=4, randomized 3 active : 1 placebo) receiving ISIS 353512 or placebo |
| CC | EXPERIMENTAL | multiple-dose cohort (n=4, randomized 3 active : 1 placebo) receiving ISIS 353512 or placebo |
| G | EXPERIMENTAL | single-dose cohort (n=4, randomized 3 active : 1 placebo) receiving ISIS 353512 or placebo |
| H | EXPERIMENTAL | single-dose cohort (n=4, randomized 3 active : 1 placebo) receiving ISIS 353512 or placebo |
| I | EXPERIMENTAL | single-dose cohort (n=4, randomized 3 active : 1 placebo) receiving ISIS 353512 or placebo |
| GG | EXPERIMENTAL | multiple-dose cohort (n=4, randomized 3 active : 1 placebo) receiving ISIS 353512 or placebo |
| HH | EXPERIMENTAL | multiple-dose cohort (n=4, randomized 3 active : 1 placebo) receiving ISIS 353512 or placebo |
| II | EXPERIMENTAL | multiple-dose cohort (n=4, randomized 3 active : 1 placebo) receiving ISIS 353512 or placebo |
| F (100 mg) | EXPERIMENTAL | single-dose cohort (n=4, randomized 3 active: 1 placebo) receiving ISIS 353512 or placebo |
| Dose-Titration 1 | EXPERIMENTAL | multiple-dose cohort (n=4, randomized 3 active: 1 placebo) receiving ISIS 353512 or placebo |
| F (200 mg) | EXPERIMENTAL | single-dose cohort (n=4, randomized 3 active: 1 placebo) receiving ISIS 353512 or placebo |
| Dose-Titration 7 | EXPERIMENTAL | multiple-dose cohort (n=4, randomized 3 active: 1 placebo) receiving ISIS 353512 or placebo |
| Name | Type | Description |
|---|---|---|
| ISIS 353512 | DRUG | 50 mg via 2 hour IV infusion, single dose |
Inclusion Criteria: * Age 18 to 55 years * Male or female although females must be post-menopausal or surgically sterile * In good health * BMI \< 32 kg/m2 * Give written informed consent to participate in the study * hsCRP at Screening ≥ 0.50 mg/L and ≤ 5.0 mg/L (for 2 measurements ≥ 2 weeks apart...