NCT03709342

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

A Pharmacodynamic and Pharmacokinetic Study of CM4620 Injectable Emulsion (CM4620-IE) in Patients With Acute Pancreatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: CalciMedica, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Pancreatitis

Interventions

Type	Name	Description
DRUG	CM4620-IE	single IV infusion on Day 1 over 4 hours

Timeline

• Start date: 2019-01-06
• Primary completion: 2019-03-07
• Completion: 2019-06-07
• First posted: 2018-10-17
• Last updated: 2022-05-03
• Results posted: 2022-05-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study