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CM4620 Injectable Emulsion

CM4620 Injectable Emulsion Versus Supportive Care in Patients With Acute Pancreatitis and SIRS

Ensayo de CalciMedica, Inc. en Acute Pancreatitis · Systemic Inflammatory Response Syndrome (del registro, en inglés).

Fase

Fase 2

Estado

Completado

Participantes

21

previstos

Centros

9

Fin del objetivo primario

feb 2019

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en mar 2018.

Qué mide

The Safety and Tolerability of CM4620-IE in Patients With Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (SIRS) or Hypoxemia. (del registro, en inglés) (90 dias)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis open-label, dose-response study will evaluate the safety and efficacy of CM4620-IE in patients with acute pancreatitis and accompanying SIRS. The study will consist of two phases. The first phase will consist of 4 female and 4 male patients (cohorts 1 and 2, respectively), enrolled concurrently, randomized in a 3:1 ratio to receive CM4620-IE plus standard of care versus standard of care alone. Planned doses for first phase will be CM4620-IE 1.0 mg/kg on Day 1 and then 1.4 mg/kg on Days 2 - 4. The second phase will consist of 8 female and 8 male patients (cohorts 3 and 4, respectively), enrolled concurrently, randomized in a 3:1 ratio to receive CM4620-IE plus standard of care versus standard of care alone. Planned doses for second phase will be CM4620-IE 2.08 mg/kg on Days 1 and 2 and then 1.6 mg/kg on Days 3 and 4. Dose escalation to second phase would only occur if needed for efficacy reasons and if no events suggesting a safety signal would occur with higher dosing. The study is not powered for the analysis of study data with inferential statisitcs as the primary purpose of the study is to explore what endpoints would be most appropriate for future trials.

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Ficha completa en ClinicalTrials.gov (NCT03401190), actualizada en mar 2026.