At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 7 enrolled
Drug / intervention
CM4620-IEdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Pharmacodynamic and Pharmacokinetic Study of CM4620 Injectable Emulsion (CM4620-IE) in Patients With Acute Pancreatitis
In Brief
A Phase 2 clinical trial evaluating CM4620-IE for Acute Pancreatitis. Completed, enrolled 7 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Pancreatitis
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedOct 2018
Enrollment StartJan 2019
Primary CompletionMar 2019
Study CompletionJun 2019
TodayJul 2026
First PostedOct 17, 2018
Enrollment StartJan 6, 2019
Primary CompletionMar 7, 2019
Study CompletionJun 7, 2019
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 7.7 years ago
Interventions
CM4620-IEdrug
single IV infusion on Day 1 over 4 hours