drugset / Trial / NCT03709342

A PK/PD Study of CM4620-IE in Patients With Acute Pancreatitis

NCT03709342 ↗

Phase 2 Completed 7 enrolled CalciMedica, Inc.
NaSingle-groupOpen-labelTreatment

Summary

This open-label study will evaluate the pharmacodynamic and pharmacokinetic profile of CM4620-IE in patients with acute pancreatitis. The first five (5) patients will receive ≤ 2.08 mg/kg of CM4620-IE by continuous IV infusion on Day 1. If necessary, up to an additional 4 patients may be treated at a different dose of CM4620-IE as determined by the obtained PK and PD data. The infusion of CM4620-IE will start within 12 hours from the time the patient or LAR provides informed consent.

Timeline

Start
2019-01-06
Primary completion
2019-03-07
Completion
2019-06-07

Drugs

EvaluationDrugModalityDoseRoute
Subject CM4620-IE Unknown 2.08 mg/kg Intravenous

Indications