Phase 1 Study of HBN-1

Status Not yet recruiting

Clinical Trial Summary

Clinical Trial Description

Phase 1 First-in Human randomized, open-label, active control standard of care study of the safety of HBN-1 administered as pharmacologically induced hypothermia as an adjunct to standard of care targeted temperature management in adult patients who have experienced out-of-hospital-cardiac arrest.

HBN-1 will be administered as an IV solution according to a weight-based escalating loading dose infusion rate scheme involving three sequential cohorts with a loading dose of HBN 1 administered over 60 minutes (Cohort A), 45 minutes (Cohort B), or 30 minutes (Cohort C). For all cohorts, the loading dose will be followed by a 12-hour maintenance infusion of HBN-1.

Dosing cohorts will include a minimum of 6 subjects randomized in a 2:1 ratio of HBN-1 plus standard of care versus standard of care alone. Individual cohorts may be expanded to up to a maximum of 12 subjects . If the cohort is expanded, the additional subjects will receive HBN-1 + SOC.

During the loading dose and maintenance infusion, physical exam, temperature, assessment of shivering, ECG, vital signs, clinical laboratory, blood alcohol level, and neurologic status will be monitored. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04094857
Study type	Interventional
Source	Hibernaid, Inc
Contact	Eric Berrios
Phone	919-433-2159
Email	eric.berrios@pharpoint.com
Status	Not yet recruiting
Phase	Phase 1
Start date	October 30, 2019
Completion date	December 31, 2020

View Details

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