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Phase 1 Study of HBN-1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04094857
Recruitment Status : Not yet recruiting
First Posted : September 19, 2019
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
Hibernaid, Inc

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, 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
Estimated Study Start Date : October 30, 2019
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiac Arrest

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



Primary Outcome Measures :
  1. Characterize the safety and recommended Phase 2 loading dose infusion rate of HBN-1 [ Time Frame: 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 [ Time Frame: Initiation of TTM until a minimum of 72 hours ]
    Number and proportion of subjects who require intervention for shivering.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04094857


Contacts
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Contact: Eric Berrios 919-433-2159 eric.berrios@pharpoint.com
Contact: Ashtyn Neuwirth 919-433-2500 ashtyn.neuwirth@pharpoint.com

Locations
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United States, Maine
Maine Medical Center
Portland, Maine, United States, 04103
Contact: David B Seder, MD    207-662-2179    sederd@mmc.org   
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15261
Contact: Adam Frisch, MD    412-647-2345    frischan@upmc.edu   
Sponsors and Collaborators
Hibernaid, Inc
Investigators
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Study Director: Laurence Katz, MD Hibernaid, Inc
Principal Investigator: David B Seder, MD Maine Medical Center

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Responsible Party: Hibernaid, Inc
ClinicalTrials.gov Identifier: NCT04094857    
Other Study ID Numbers: HBN-1-001-US
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: October 7, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Heart Arrest
Heart Diseases
Cardiovascular Diseases