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Phase 1 Study of HBN-1

Primary Purpose

Cardiac Arrest

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
HBN-1
Sponsored by
Hibernaid, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest focused on measuring therapeutic temperature management; therapeutic hypothermia

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maine Medical Center
  • University of Pittsburgh Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

HBN-1 Plus Standard of Care

Standard of Care

Arm Description

Subjects will receive an intravenous loading dose of HBN-1 followed by a 12 hour maintenance infusion plus standard of care targeted temperature management

Subjects will receive standard of care targeted temperature management only

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Determine the incidence of the need for implementation of treatment to offset shivering
Number and proportion of subjects who require intervention for shivering.

Full Information

First Posted
September 17, 2019
Last Updated
October 3, 2019
Sponsor
Hibernaid, Inc
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1. Study Identification

Unique Protocol Identification Number
NCT04094857
Brief Title
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

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 30, 2019 (Anticipated)
Primary Completion Date
November 1, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hibernaid, Inc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
therapeutic temperature management; therapeutic hypothermia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Randomized, open-label
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HBN-1 Plus Standard of Care
Arm Type
Experimental
Arm Description
Subjects will receive an intravenous loading dose of HBN-1 followed by a 12 hour maintenance infusion plus standard of care targeted temperature management
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Subjects will receive standard of care targeted temperature management only
Intervention Type
Drug
Intervention Name(s)
HBN-1
Intervention Description
Intravenous infusion
Primary Outcome Measure Information:
Title
Characterize the safety and recommended Phase 2 loading dose infusion rate of HBN-1
Description
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)
Time Frame
Initiation of TTM until a minimum of 72 hours
Secondary Outcome Measure Information:
Title
Determine the incidence of the need for implementation of treatment to offset shivering
Description
Number and proportion of subjects who require intervention for shivering.
Time Frame
Initiation of TTM until a minimum of 72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 40 to 80 years, inclusive Documented diagnosis of OHCA with ventricular tachycardia/fibrillation, asystole or pulseless electrical activity Return of spontaneous circulation within 50 minutes of the event FOUR Motor Score <4 Maximum estimated weight not to exceed 100 kg Exclusion Criteria: Return of spontaneous circulation >8 hours Known history of prior cardiac arrest, alcohol, or substance abuse or dependence Presumed etiology of cardiac arrest is trauma, hemorrhage, or sepsis Comfort measures only or anticipated withdrawal of life-support within 24 hours Is within a protected population group (eg, pregnant or breastfeeding or incarcerated persons) Has history or evidence of significant hepatic dysfunction (Sequential Organ Failure Assessment Hepatic score >2) 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 Is able to obey to verbal commands Is receiving IV vasopressin or lidocaine hydrochloride
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Berrios
Phone
919-433-2159
Email
eric.berrios@pharpoint.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ashtyn Neuwirth
Phone
919-433-2500
Email
ashtyn.neuwirth@pharpoint.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurence Katz, MD
Organizational Affiliation
Hibernaid, Inc
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
David B Seder, MD
Organizational Affiliation
MaineHealth
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04103
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David B Seder, MD
Phone
207-662-2179
Email
sederd@mmc.org
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Frisch, MD
Phone
412-647-2345
Email
frischan@upmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Phase 1 Study of HBN-1

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