Cardiac ArrestPhase 1NCT04094857
Phase 1 Study of HBN-1
A Phase 1 study testing HBN-1 in people with Cardiac Arrest, run by Hibernaid, Inc at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- HBN-1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Oct 2019to 31 Dec 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15261
Adam Frisch, MD, 412-647-2345, frischan@upmc.edu
Maine Medical Center
Portland, Maine, 04103
David B Seder, MD, 207-662-2179, sederd@mmc.org
About this study
Official title: A Phase 1 First-In-Human Study of HBN-1 in Patients Resuscitated Following Out-of-Hospital Cardiac Arrest
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.
Read the 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.
- Conditions
- Cardiac Arrest
- Being tested
- HBN-1
- Keywords
- therapeutic temperature management; therapeutic hypothermia
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBN-1Drug
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: HBN-1 |
| Standard of Care | No intervention | Subjects will receive standard of care targeted temperature management only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Number and proportion of subjects who require intervention for shivering.
Measured: Initiation of TTM until a minimum of 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start30 Oct 2019 (estimated)
- Primary completion1 Nov 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, open-label
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hibernaid, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laurence Katz, MD, Study director, Hibernaid, IncDavid B Seder, MD, Principal investigator, MaineHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094857
- Sponsor's protocol ID
- HBN-1-001-US
- Status last verified
- Sep 2019
- First submitted
- 17 Sep 2019
- Last updated
- 7 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 First-In-Human Study of HBN-1 in Patients Resuscitated Following Out-of-Hospital Cardiac Arrest
- ClinicalTrials.gov ID
- NCT04094857
- Acronym / sponsor ID
- HBN-1-001-US
- Conditions
- Cardiac Arrest
- Keywords
- therapeutic temperature management; therapeutic hypothermia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Hibernaid, IncIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2019 (estimated)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 19 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, open-label
| Arm | Type | Receives |
|---|---|---|
| HBN-1 Plus Standard of Care | Experimental | Drug: HBN-1Subjects will receive an intravenous loading dose of HBN-1 followed by a 12 hour maintenance infusion plus standard of care targeted temperature management |
| Standard of Care | No intervention | –Subjects will receive standard of care targeted temperature management only |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HBN-1Intravenous infusion | Drug | HBN-1 Plus Standard of Care |
Primary outcome
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)
1 secondary outcome
Determine the incidence of the need for implementation of treatment to offset shivering
Time frame: Initiation of TTM until a minimum of 72 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurence Katz, MD study director
Hibernaid, Inc
David B Seder, MD principal investigator
MaineHealth
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HBN-1 in people with Cardiac Arrest, run by Hibernaid, Inc at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eric Berrios (919-433-2159, eric.berrios@pharpoint.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2019.