drugset / Trial / NCT03709342
A PK/PD Study of CM4620-IE in Patients With Acute Pancreatitis
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CM4620-IE | Unknown | 2.08 mg/kg | Intravenous |