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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02035605 | A Phase 1 Study of an Investigational Drug, ALN-AT3SC, in Healthy Volunteers and Hemophilia A or B Patients | PHASE1 | COMPLETED | 51 | — | — | Jan 20, 2014 | Jul 20, 2017 | Dec 19, 2020 | 14 | United States, Bulgaria +3 |
| Arm | Type | Description |
|---|---|---|
| ALN-AT3SC | ACTIVE_COMPARATOR | - |
| Sterile Normal Saline (0.9% NaCl) | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| ALN-AT3SC | DRUG | Ascending doses of ALN-AT3SC by subcutaneous (sc) injection |
| Sterile Normal Saline (0.9% NaCl) | DRUG | Calculated volume to match active comparator |
Inclusion Criteria: Part A (SAD phase) inclusion: * Healthy adult males aged 18 to 40 years inclusive at Screening. * Subjects with adequate complete blood counts and liver function tests. * Willing to provide written informed consent and willing to comply with study requirements. Part B \& C (MA...