Phase 1 Study of HBN-1

• Sponsor: Hibernaid, Inc (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT04094857
• Collaborator: (none)
• Enrollment: 18
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 14.1
• Patients Per Site: 9
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Arrest	Drug: HBN-1	Phase 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 Design

• Study Type: Interventional
• Anticipated Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized, open-labelRandomized, open-label
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1 First-In-Human Study of HBN-1 in Patients Resuscitated Following Out-of-Hospital Cardiac Arrest
• Anticipated Study Start Date: Oct 30, 2019
• Anticipated Primary Completion Date: Nov 1, 2020
• Anticipated Study Completion Date: Dec 31, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Maine Medical Center	Portland	Maine	United States	04103
2	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15261

Sponsors and Collaborators

• Hibernaid, Inc

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hibernaid, Inc
• ClinicalTrials.gov Identifier: NCT04094857
• Other Study ID Numbers: HBN-1-001-US
• First Posted: Sep 19, 2019
• Last Update Posted: Oct 7, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hibernaid, Inc: therapeutic temperature management; therapeutic hypothermia
• Additional relevant MeSH terms: Heart Arrest

Study Results

No Results Posted as of Oct 7, 2019