Phase 1 Study of HBN-1

Status unconfirmed · Phase 1

Conditions studied: Cardiac Arrest

In brief

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 IV as a loading dose infusion followed by a 12-hour maintenance infusion.

Key facts

Study ID

NCT04094857

Run by

Hibernaid, Inc

People needed

18

Starts

2019-10-30

Expected to finish

2020-12-31

Last updated by the study team

2019-10-07

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 40 to 80 years, inclusive
• Documented diagnosis of OHCA with ventricular tachycardia/fibrillation, asystole or pulseless electrical activity
• Return of spontaneous circulation within 50 minutes of the event
• FOUR Motor Score <4
• Maximum estimated weight not to exceed 100 kg

You may not qualify if…

• Return of spontaneous circulation >8 hours
• Known history of prior cardiac arrest, alcohol, or substance abuse or dependence
• Presumed etiology of cardiac arrest is trauma, hemorrhage, or sepsis
• Comfort measures only or anticipated withdrawal of life-support within 24 hours
• Is within a protected population group (eg, pregnant or breastfeeding or incarcerated persons)
• Has history or evidence of significant hepatic dysfunction (Sequential Organ Failure Assessment Hepatic score >2)
• Any other condition, that in the opinion of the investigator, would preclude the subject from being a suitable candidate, e.g. end-stage chronic illness with no reasonable expectation of survival to hospital discharge
• Is able to obey to verbal commands
• Is receiving IV vasopressin or lidocaine hydrochloride

Where it is running

• Maine Medical Center — Portland, Maine, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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