Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ISIS 353512 · 1 trial · 1 indication
| 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...
ISIS 353512 is an investigational small molecule being developed for the treatment of inflammatory diseases. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and tolerability in humans.
ISIS 353512 is being developed by Ionis Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol IONS. The company is conducting clinical trials to evaluate the safety and tolerability of this investigational drug in healthy volunteers.
ISIS 353512 is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. A Phase 1 trial has been completed to assess its safety and tolerability in healthy volunteers, but it remains in early-stage clinical development.
ISIS 353512 has one completed Phase 1 clinical trial registered as NCT00734240, titled "Safety and Tolerability of Single and Multiple Doses of ISIS 353512 in Healthy Volunteers." The trial enrolled 103 participants in Canada and was a randomized, double-blind, controlled study.
ISIS 353512 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for inflammatory diseases. The completed Phase 1 trial focused on safety and tolerability in healthy volunteers, and the drug has not yet progressed to later-stage trials or received regulatory approval.