Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RUC-4 Compound · 1 trial · 1 indication
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...
RUC-4 is an investigational small molecule being developed for Coronary Disease. It is administered subcutaneously and is currently in Phase 1 clinical development. The drug is being studied in a randomized, double-blind, controlled dose-escalation trial to evaluate its safety and tolerability in patients with Coronary Disease.
RUC-4 is a small molecule that targets a specific molecular pathway involved in Coronary Disease. The exact molecular target has not been disclosed in available information. The drug is designed to be administered subcutaneously and is being evaluated in a Phase 1 clinical trial for its safety and efficacy in patients with Coronary Disease.
RUC-4 is being developed by Precision BioSciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol DTIL. The company is conducting a Phase 1 clinical trial of RUC-4 for the treatment of Coronary Disease.
RUC-4 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial is a randomized, double-blind, controlled dose-escalation study that has been completed, with 44 participants enrolled.
RUC-4 has one completed Phase 1 clinical trial registered under NCT03844191. The trial was a randomized, double-blind, controlled dose-escalation study of subcutaneously administered RUC-4 in patients with Coronary Disease. The study enrolled 44 participants in the United States and included healthy volunteers.
RUC-4 is also known as RUC-4 Compound. Both names refer to the same investigational small molecule being developed by Precision BioSciences, Inc. for Coronary Disease. The drug is currently in Phase 1 clinical development and has completed a dose-escalation trial.