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Also known as CM4620 Injectable Emulsion (Low Dose)
CM4620 Injectable Emulsion · 1 trial · 2 indications
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...
CM4620 Injectable Emulsion is an investigational small molecule developed by CalciMedica, Inc. for acute pancreatitis. It is also known as CM4620 Injectable Emulsion (Low Dose). The drug is in Phase 2 clinical development and has been studied in patients with acute pancreatitis and systemic inflammatory response syndrome.
CM4620 Injectable Emulsion is being developed for the treatment of acute pancreatitis, a gastrointestinal condition. It has been studied specifically in patients with acute pancreatitis and systemic inflammatory response syndrome (SIRS). The drug is investigational and has not been approved for any indication.
CM4620 Injectable Emulsion is made by CalciMedica, Inc., a biopharmaceutical company. CalciMedica trades on the stock market under the ticker symbol CALC. The company is responsible for the development of this investigational therapy for acute pancreatitis.
CM4620 Injectable Emulsion is in Phase 2 clinical development. It has completed one Phase 2 trial and is not currently active in any trials. The drug remains investigational and has not been approved by the FDA for any indication.
CM4620 Injectable Emulsion has been studied in one completed Phase 2 clinical trial, NCT03401190. The trial was titled CM4620 Injectable Emulsion Versus Supportive Care in Patients With Acute Pancreatitis and SIRS. It enrolled 21 patients in the United States and was randomized but not double-blind, with a no-treatment control.
Yes, CM4620 Injectable Emulsion is also known as CM4620 Injectable Emulsion (Low Dose). Both names refer to the same investigational drug developed by CalciMedica, Inc. for acute pancreatitis. The low dose designation distinguishes it from other formulations or dosing regimens.