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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00519727 | Safety Study of ISIS 325568 in Healthy Volunteers | PHASE1 | COMPLETED | 60 | — | — | Aug 1, 2007 | Jun 1, 2008 | Aug 19, 2008 | 1 | Netherlands |
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | 50 mg ISIS 325568 vs Placebo, s.c. injection |
| B | EXPERIMENTAL | 100 mg ISIS 325568 vs Placebo , s.c. injection |
| C | EXPERIMENTAL | 200 mg ISIS 325568 vs Placebo , s.c. injection |
| D | EXPERIMENTAL | 400 mg ISIS 325568 vs Placebo, s.c. injection |
| AA | EXPERIMENTAL | 50 mg ISIS 325568, 3x over 1 week i.v. infusion, weekly s.c. injection for 5 weeks vs Placebo |
| BB | EXPERIMENTAL | 100 mg ISIS 325568, 3x over 1 week i.v. infusion, weekly s.c. injection for 5 weeks vs Placebo |
| CC | EXPERIMENTAL | 200 mg ISIS 325568, 3x over 1 week i.v. infusion, weekly s.c. injection for 5 weeks vs Placebo |
| DD | EXPERIMENTAL | 400 mg ISIS 325568, 3x over 1 week i.v. infusion, weekly s.c. injection for 5 weeks vs Placebo |
| Name | Type | Description |
|---|---|---|
| ISIS 325568 | DRUG | 4 arms of single dose s.c. injections: A 50 mg B 100 mg C 200 mg D 400 mg 4 arms of multi-dose: 3 i.v. infusions over 1 week followed by 5 weekly s.c. injections AA 50 mg BB 100 mg CC 200 mg DD 400 mg or EE 50 mg Placebo: 0.9% Sodium Chloride |
Inclusion Criteria: 1. Age 18 to 65 years 2. Males or females. Females must be non-pregnant and non-lactating, and either surgically sterile (hysterectomy, oophorectomy, or tubal ligation) or post-menopausal. Males must be surgically sterile, abstinent or if engaged in sexual relations of child-bea...