Phase 1 Study of HBN-1
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|ClinicalTrials.gov Identifier: NCT04094857|
Recruitment Status : Not yet recruiting
First Posted : September 19, 2019
Last Update Posted : October 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Arrest||Drug: HBN-1||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized, open-label|
|Masking:||None (Open Label)|
|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|
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
No Intervention: Standard of Care
Subjects will receive standard of care targeted temperature management only
- 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)
- 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.
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
|Contact: Eric Berriosfirstname.lastname@example.org|
|Contact: Ashtyn Neuwirthemail@example.com|
|United States, Maine|
|Maine Medical Center|
|Portland, Maine, United States, 04103|
|Contact: David B Seder, MD 207-662-2179 firstname.lastname@example.org|
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15261|
|Contact: Adam Frisch, MD 412-647-2345 email@example.com|
|Study Director:||Laurence Katz, MD||Hibernaid, Inc|
|Principal Investigator:||David B Seder, MD||Maine Medical Center|