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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03844191 | A Randomized Phase 1 Dose-Escalation Study of Subcutaneously(SC) Administered RUC-4 | PHASE1 | COMPLETED | 44 | — | — | Feb 18, 2019 | Dec 1, 2019 | Aug 27, 2024 | 1 | United States |
inhibition of platelet aggregation
| Arm | Type | Description |
|---|---|---|
| Part 1 Cohort 1 | EXPERIMENTAL | Cohort 1: 0.05 mg/kg RUC-4/placebo 7 subjects will be enrolled: 6 subjects will receive a single subcutaneous dose of RUC-4 and 1 subject will receive matched placebo. |
| Part 1 Cohort 2 | EXPERIMENTAL | Cohort 2: 0.075 mg/kg RUC-4/placebo 7 subjects will be enrolled: 6 subjects will receive a single subcutaneous dose of RUC-4 and 1 subject will receive matched placebo. |
| Part 2 Cohort 1 | EXPERIMENTAL | Cohort 1: initial dose to be selected by the Safety Review Committee (SRC) after completion of Part 1 (the same initial dose used in Part 1 or one of the previously studied higher doses that is lower than the overall RUC-4 BED) 7 subjects will be enrolled: 6 subjects will receive a single subcutaneous dose of RUC-4 and 1 subject will receive matched placebo. |
| Part 2 Cohorts 2-3 | EXPERIMENTAL | 7 subjects (6 receiving RUC-4, 1 receiving placebo) will be enrolled in each dose cohort, with a safety evaluation performed after 2 subjects in a dose cohort receive RUC 4 and at the completion of dosing for all subjects in the dose cohort. Dose escalation to be determined by the SRC charter and will continue until identification of the overall RUC-4 BED or MTD |
| Part 2 Dose Expansion Cohort 1 | EXPERIMENTAL | 14 subjects will receive a selected dose of RUC-4 based on SRC review of dose escalation data. In the expansion cohort, 7 subjects weighing 55 to 65 kg and 7 subjects weighing 100 to 120 kg will be enrolled; 12 subjects will receive a single subcutaneous dose of RUC-4 and 2 will receive matched placebo |
| Name | Type | Description |
|---|---|---|
| RUC-4 Compound | DRUG | single subcutaneous administration of RUC-4 |
Main Inclusion Criteria (all subjects) * weight between 55-120 kg, inclusive, and BMI between 18-38 kg/m2 * females must be non-pregnant, non-lactating, and of non-childbearing potential. * good general health as determined by no acute illness and no clinically significant abnormal findings on medi...