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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00873431 | Open-Label Study Assessing The Safety, Immunogenicity and Dose Response of IC47 | PHASE1 | COMPLETED | 32 | — | — | Mar 1, 2009 | Feb 1, 2010 | Oct 19, 2012 | 1 | Germany |
| Arm | Type | Description |
|---|---|---|
| IC47 30 mcg | EXPERIMENTAL | 30 mcg with Alum |
| IC47 30 mcg w/o | EXPERIMENTAL | 30 mcg without Alum |
| IC47 150 mcg | EXPERIMENTAL | 150 mcg with Alum |
| IC47 150 mcg w/o | EXPERIMENTAL | 150 mcg without Alum |
| Name | Type | Description |
|---|---|---|
| IC47 | BIOLOGICAL | solution/suspension for i.m. injection dosage: 30/150 mcg frequency: 3 times at Day 0, Day 42 and Day 84 |
Inclusion Criteria: * Written informed consent * Healthy adults ≥ 18 to \</= 65 * female subjects: post-menopausal or practicing reliable methods of contraception during the study Exclusion Criteria: * History of autoimmune diseases and malignancies. * History of severe hypersensitivity reactions...