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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03401190 | CM4620 Injectable Emulsion Versus Supportive Care in Patients With Acute Pancreatitis and SIRS | PHASE2 | COMPLETED | 21 | — | — | Mar 12, 2018 | Apr 30, 2019 | Mar 30, 2026 | 9 | United States |
Safety and tolerability will be assessed by monitoring the frequency, duration and severity of treatment-emergent adverse events (TEAEs) throughout the study period.
| Arm | Type | Description |
|---|---|---|
| Low Dose Group | EXPERIMENTAL | Phase 1: Cohorts 1 \& 2 will consist of 4 female and 4 male patients enrolled concurrently who will be randomized 3:1 to receive CM4620-IE plus standard of care versus standard of care alone. Planned doses for patients who are randomized to receive CM4620-IE are 1.0 mg/kg on Days 1 and 1.4 mg/kg on Days 2-4. |
| High Dose Group | EXPERIMENTAL | Phase 2: Cohorts 3 \& 4 will consist of 8 female and 8 male patients enrolled concurrently who will be randomized 3:1 to receive CM4620-IE plus standard of care versus standard of care alone. Planned doses for patients who are randomized to receive CM4620-IE are 2.08 mg/kg of CM4620-IE on Days 1 and 2, and 1.6 mg/kg on Days 3 and 4. |
| Standard of Care | NO_INTERVENTION | For all cohorts, patients will be randomized 3:1 to CM4620-IE plus standard of care versus standard of care alone. |
| Name | Type | Description |
|---|---|---|
| CM4620 Injectable Emulsion (Low Dose) | DRUG | CM4620-IE 1.0 mg/kg on Day 1 and then 1.4 mg/kg on Days 2-4, during the first phase of the study (Cohorts 1 and 2). All doses of CM4620-IE will be administered intravenously (IV) over 4 hours. |
| CM4620 Injectable Emulsion (High Dose) | DRUG | CM4620-IE 2.08 mg/kg on Days 1 and 2 and then 1.6 mg/kg on Days 3 and 4, during the second phase of the study (Cohorts 3 and 4). All doses of CM4620-IE will be administered intravenously (IV) over 4 hours. |
Inclusion Criteria: 1. Diagnosis of acute pancreatitis established by the presence of abdominal pain consistent with acute pancreatitis and 1 of the following 2 criteria: 1. Serum lipase and/or serum amylase \> 3 times the upper limit of normal (ULN); 2. Characteristic findings of acute panc...