Phase 1 Study of HBN-1

NCT04094857 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: HBN-1-001-US
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

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.

Conditions

Cardiac Arrest

Keywords

therapeutic temperature management; therapeutic hypothermia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Determine the incidence of the need for implementation of treatment to offset shivering

  Initiation of TTM until a minimum of 72 hours

Study Arms (2)

HBN-1 Plus Standard of Care

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

Subjects will receive standard of care targeted temperature management only

Interventions

HBN-1 DRUG

Intravenous infusion

HBN-1 Plus Standard of Care

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hibernaid, Inc: lead

Study Sites (2)

Maine Medical Center

Portland, Maine, 04103, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15261, United States

Location

MeSH Terms

Conditions

Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Laurence Katz, MD

  Hibernaid, Inc

  STUDY DIRECTOR

• David B Seder, MD

  MaineHealth

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric Berrios

CONTACT

919-433-2159; eric.berrios@pharpoint.com

Ashtyn Neuwirth

CONTACT

919-433-2500; ashtyn.neuwirth@pharpoint.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, open-label

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 19, 2019
• Study Start: October 30, 2019
• Primary Completion: November 1, 2020
• Study Completion: December 31, 2020
• Last Updated: October 7, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)