Phase 1 Study of HBN-1

Cardiac Arrest Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04094857
• Other study ID #: HBN-1-001-US
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: October 30, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: September 2019
• Source: Hibernaid, Inc
• Contact: Eric Berrios
• Phone: 919-433-2159
• Email: eric.berrios[@]pharpoint.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 18
• Est. completion date: December 31, 2020
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

Intervention

Drug:
• HBN-1
Intravenous infusion

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Maine Medical Center	Portland	Maine

Sponsors (1)

Lead Sponsor	Collaborator
Hibernaid, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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