Clinical trial NCT04094857: Phase 1 Study of HBN-1
Official title: A Phase 1 First-In-Human Study of HBN-1 in Patients Resuscitated Following Out-of-Hospital Cardiac Arrest
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Cardiac Arrest
Keywords: therapeutic temperature management; therapeutic hypothermia
Lead sponsor: Hibernaid, Inc
Sponsor class: INDUSTRY
First posted: 2019-09-19
Enrollment: 18
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, open-label
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Characterize the safety and recommended Phase 2 loading dose infusion rate of HBN-1
timeFrame: Initiation of TTM until a minimum of 72 hours
Secondary outcomes:
measure: Determine the incidence of the need for implementation of treatment to offset shivering
timeFrame: Initiation of TTM until a minimum of 72 hours
Other outcomes:
Locations:
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: Hibernaid, Inc
name: Laurence Katz, MD
role: STUDY_DIRECTOR
affiliation: MaineHealth
name: David B Seder, MD
role: PRINCIPAL_INVESTIGATOR
References: