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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02314442 | A Phase 1 Study of an Investigational Drug, ALN-PCSSC, in Subjects With Elevated Low Density Lipoprotein Cholesterol (LDL-C) | PHASE1 | COMPLETED | 70 | — | — | Dec 1, 2014 | Nov 1, 2015 | Dec 17, 2015 | 2 | United Kingdom |
| Arm | Type | Description |
|---|---|---|
| ALN-PCSSC | ACTIVE_COMPARATOR | - |
| Sterile Normal Saline (0.9% NaCl) | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| ALN-PCSSC | DRUG | Single or multiple doses of ALN-PCSSC 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 * Female subjects must be of non-childbearing potential; e.g. post-menopausal or pre-menopausal with surgical sterilization * Male subjects agree to use appropriate contraception * Willing to provide written informed con...