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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02352493 | A Phase 1/2 Study of an Investigational Drug, ALN-CC5, in Healthy Adult Volunteers and Patients With PNH | PHASE1 | COMPLETED | 62 | — | — | Jan 1, 2015 | Aug 1, 2017 | Mar 30, 2020 | 4 | Spain, United Kingdom |
Adverse events were reported for single-ascending doses (SAD) or multiple ascending doses (MAD) of ALN-CC5 when administered to healthy adult subjects and of multiple doses (MD) in patients with paroxysmal nocturnal hemoglobinuria (PNH)
| Arm | Type | Description |
|---|---|---|
| ALN-CC5 | ACTIVE_COMPARATOR | - |
| Sterile Normal Saline (0.9% NaCl) | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| ALN-CC5 | DRUG | Single or multiple doses of ALN-CC5 by subcutaneous (sc) injection |
| Sterile Normal Saline (0.9% NaCl) | DRUG | calculated volume to match active comparator |
Inclusion Criteria: * Adequate complete blood counts, liver and renal function * 12-lead electrocardiogram (ECG) within normal limits * Female subjects of child bearing potential agreeing to use a protocol specified method of contraception * Male subjects agreeing to use protocol specified methods ...