Cardiac Arrest
Conditions
Keywords
therapeutic temperature management; therapeutic hypothermia
Brief summary
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.
Detailed 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.
Interventions
DRUGHBN-1
Intravenous infusion
Sponsors
Hibernaid, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized, open-label
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age 40 to 80 years, inclusive 2. Documented diagnosis of OHCA with ventricular tachycardia/fibrillation, asystole or pulseless electrical activity 3. Return of spontaneous circulation within 50 minutes of the event 4. FOUR Motor Score \<4 5. Maximum estimated weight not to exceed 100 kg
Exclusion criteria
1. Return of spontaneous circulation \>8 hours 2. Known history of prior cardiac arrest, alcohol, or substance abuse or dependence 3. Presumed etiology of cardiac arrest is trauma, hemorrhage, or sepsis 4. Comfort measures only or anticipated withdrawal of life-support within 24 hours 5. Is within a protected population group (eg, pregnant or breastfeeding or incarcerated persons) 6. Has history or evidence of significant hepatic dysfunction (Sequential Organ Failure Assessment Hepatic score \>2) 7. 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 8. Is able to obey to verbal commands 9. Is receiving IV vasopressin or lidocaine hydrochloride
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Characterize the safety and recommended Phase 2 loading dose infusion rate of HBN-1 | Initiation of TTM until a minimum of 72 hours | Safety and tolerability based on evaluation of adverse events, serious adverse events, physical examinations, vital signs measurements, electrocardiograms, and changes in clinical laboratory values (hematology, biochemistry, and urinalysis) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determine the incidence of the need for implementation of treatment to offset shivering | Initiation of TTM until a minimum of 72 hours | Number and proportion of subjects who require intervention for shivering. |
Countries
United States
Contacts
Primary ContactEric Berrios
Backup ContactAshtyn Neuwirth
Outcome results
None listed