Phase 1 Study of HBN-1

A Phase 1 First-In-Human Study of HBN-1 in Patients Resuscitated Following Out-of-Hospital Cardiac Arrest

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.

Study Overview

• Status: Unknown
• Conditions: Cardiac Arrest
• Intervention / Treatment: Drug: HBN-1

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.

• Study Type: Interventional
• Enrollment (Anticipated): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Maine
    • Portland, Maine, United States, 04103
      • Maine Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15261
      • University of Pittsburgh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HBN-1 Plus Standard of Care; Subjects will receive an intravenous loading dose of HBN-1 followed by a 12 hour maintenance infusion plus standard of care targeted temperature management	Drug: HBN-1; Intravenous infusion
No Intervention: Standard of Care; Subjects will receive standard of care targeted temperature management only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterize the safety and recommended Phase 2 loading dose infusion rate of HBN-1	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)	Initiation of TTM until a minimum of 72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the incidence of the need for implementation of treatment to offset shivering	Number and proportion of subjects who require intervention for shivering.	Initiation of TTM until a minimum of 72 hours

Collaborators and Investigators

• Sponsor: Hibernaid, Inc
• Investigators: Study Director: Laurence Katz, MD, Hibernaid, Inc; Principal Investigator: David B Seder, MD, MaineHealth

Study record dates

Study Major Dates

• Study Start (Anticipated): October 30, 2019
• Primary Completion (Anticipated): November 1, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: September 17, 2019
• First Submitted That Met QC Criteria: September 17, 2019
• First Posted (Actual): September 19, 2019

Study Record Updates

• Last Update Posted (Actual): October 7, 2019
• Last Update Submitted That Met QC Criteria: October 3, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: therapeutic temperature management; therapeutic hypothermia
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• Other Study ID Numbers: HBN-1-001-US

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No