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A Phase 1-2a Study of CXL-1020-01 in Patients with Stable Heart Failure
This is a Phase I/IIa Dose-Escalation, First exposure in Humans, Study Evaluating the Safety and Tolerability of CXL-1020 and Specific Effects on Electrocardiographic and Non-Invasive Hemodynamic Parameters in Patients with Chronic Heart Failure. 4 weekly four-hour treatments involving ascending dosages of CXL-1020 with a randomly interspersed placebo dose within two or more unique patient cohorts. Separate echocardiography cohorts (Echo Cohort A and Echo Cohort B) will evaluate a sustained dose over 4 hours (ECHO A), and an ascending two dose level, 4-hour infusion (2 hours each) (ECHO B), in individual patients. Echo Cohort dosages will be determined from responses observed in previous cohort exposures.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
CXL-1020, CXL-1020, Placebo for CXL-1020 Cohort 1, Placebo for CXL-1020 Cohort 2, CXL-1020 Dose for Echo Cohort A, CXL-1020 Doses for Echo Cohort B
Orange County Clinical Research Center
Cardioxyl Pharmaceuticals, Inc
Published on BioPortfolio: 2014-07-23T21:09:45-0400
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