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.

开始日期2019-10-30

申办/合作机构

Hibernaid, Inc.

100 项与 HBN-1 相关的临床结果

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100 项与 HBN-1 相关的转化医学

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100 项与 HBN-1 相关的专利（医药）

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项与 HBN-1 相关的文献（医药）

2015-07-01·Resuscitation1区 · 医学

Effect of a pharmacologically induced decrease in core temperature in rats resuscitated from cardiac arrest

1区 · 医学

Article

作者: Katz, Laurence M ; Lambert, Brice H ; McGwin, Gerald ; Frank, Jonathan E ; Gordon, Christopher J ; Glickman, Lawrence T

AIMHypothermia is recommended by international guidelines for treatment of unconscious survivors of cardiac arrest to improve neurologic outcomes. However, temperature management is often underutilized because it may be difficult to implement. The present study evaluated the efficacy of pharmacologically induced hypothermia on survival and neurological outcome in rats resuscitated from cardiac arrest.METHODSCardiac arrest was induced for 10 min in 120 rats. Sixty-one rats were resuscitated and randomized to normothermia, physical cooling or pharmacological hypothermia 5 min after resuscitation. Pharmacological hypothermia rats received a combination of ethanol, vasopressin and lidocaine (HBN-1). Physical hypothermia rats were cooled with intravenous iced saline and cooling pads. Rats in the pharmacological hypothermia group received HBN-1 at ambient temperature (20 °C). Normothermic rats were maintained at 37.3 ± 0.2 °C.RESULTSHBN-1 (p < 0.0001) shortened the time (85 ± 71 min) to target temperature (33.5 °C) versus physical hypothermia (247 ± 142 min). The duration of hypothermia was 17.0 ± 6.8h in the HBN-1 group and 17.3 ± 7.5h in the physical hypothermia group (p = 0.918). Survival (p = 0.034), neurological deficit scores (p < 0.0001) and Morris Water Maze performance after resuscitation (p = 0.041) was improved in the HBN-1 versus the normothermic group. HBN-1 improved survival and early neurological outcome compared to the physical hypothermia group while there was no significant difference in performance in the Morris water maze.CONCLUSIONHBN-1 induced rapid and prolonged hypothermia improved survival with good neurological outcomes after cardiac arrest suggesting that pharmacologically induced regulated hypothermia may provide a practical alternative to physical cooling.

2012-12-01·Therapeutic Hypothermia and Temperature Management4区 · 医学

Drug-Induced Therapeutic Hypothermia After Asphyxial Cardiac Arrest in Swine

4区 · 医学

Article

作者: Katz, Laurence M. ; McGwin, Gerald ; Gordon, Christopher J.

A feasibility study was performed to compare an investigational drug, HBN-1, to forced cooling to induce hypothermia after resuscitation in a translation model of asphyxial cardiac arrest in swine. Serum and cerebral spinal fluid neuron-specific enolase activity (sNSE and csfNSE) were measured after cardiac arrest as surrogate markers of brain injury. In a block design, swine resuscitated from 10 minutes of asphyxial cardiac arrest were infused intravenously with HBN-1 or iced saline vehicle (forced hypothermia [FH]) 5 to 45 minutes after return of spontaneous circulation (ROSC). External cooling in both groups was added 45 minutes after ROSC until hypothermia (T=4°C below baseline) was attained. Esophageal (core) temperature, shivering, cardiopulmonary parameters, and time to hypothermia after ROSC were monitored. sNSE and csfNSE were measured 180 minutes after ROSC. HBN-1 induced hypothermia significantly lowered temperature compared to FH 5-45 minutes after ROSC (p<0.0001). Time to hypothermia was reduced by HBN-1 (93±6 minutes) compared to FH (177±10 minutes) (p<0.0001). HBN-1 sNSE (0.7±1.9 ng/mL) and csfNSE (17.3±1.9 ng/mL) were lower compared to FH (6±1.6 ng/mL) and (49.7±32.0 ng/mL) (p<0.0001, p=0.022, respectively). There was no shivering with HBN-1 cooling while all FH cooled swine shivered (p<0.0001). The time to reach target hypothermia after cardiac arrest was reduced by nearly 50% with HBN-1 compared to the FH method of inducing hypothermia. Moreover, surrogate biomarkers of brain injury were significantly reduced with HBN-1 as compared to FH. While HBN-1-induced hypothermia shows promise for being neuroprotective, survival studies are needed to confirm these preliminary findings.

2012-06-01·Therapeutic Hypothermia and Temperature Management4区 · 医学

Induction of a Prolonged Hypothermic State by Drug-induced Reduction in the Thermoregulatory Set-Point

4区 · 医学

Article

作者: Katz, Laurence M. ; McGwin, Gerald ; Frank, Jonathan E. ; Finch, Alex ; Gordon, Christopher J.

BACKGROUNDThe marked improvement in outcome following induction of hypothermia after cardiac arrest has spurred the search for better methods to induce cooling. A regulated decrease in core temperature mediated by a drug-induced reduction in the set point for thermoregulation may be an ideal means of inducing hypothermia. To this end, the exploratory drug HBN-1 was assessed as a means to induce mild and prolonged hypothermia.METHODSFree moving rats were infused i.v. for 12 hours with: a vehicle at room temperature (normothermia), a vehicle chilled to 4°C (forced hypothermia), or HBN-1 (mixture of ethanol, lidocaine, and vasopressin) at room temperature. Core (intra-abdominal) temperature (Tc) was measured telemetrically, tail skin temperature (Ttail) by infrared thermography, metabolic rate (MR) was estimated with indirect calorimetery, and shivering was scored visually.RESULTSHBN-1 elicited a reduction in Tc from 37.5°C to 34°C within 80 minutes after initiation of the infusion; Tc was maintained between 33°C and 34°C for more than 13 hours. HBN-1 infusion was associated with a reduction in MR (p=0.0006), a slight reduction in Ttail, and no evidence of shivering (p<0.001). The forced hypothermia group displayed shivering (p<0.001), a significant increase in MR, and a decrease in Ttail, indicative of peripheral vasoconstriction to reduce heat loss.CONCLUSIONHBN-1 infusion induced a mild and prolonged hypothermia in free moving, unanesthetized rats characterized by modulation of thermoeffectors to reduce heat gain and increase heat loss. HBN-1 thus appears to elicit regulated hypothermia and may provide a new method for achieving a prolonged state of therapeutic hypothermia.

100 项与 HBN-1 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
心脏停搏	临床2期	美国	Hibernaid, Inc.	2019-10-30
脑卒中	临床2期	美国	The University of North Carolina at Chapel Hill	2012-12-16
脑损伤	临床2期	美国	The University of North Carolina at Chapel Hill	-
脓毒症	临床2期	美国	The University of North Carolina at Chapel Hill	-
创伤性脑损伤	临床1期	-	Hibernaid, Inc.	-
创伤性脑损伤	临床1期	-	The University of North Carolina at Chapel Hill	-
脓毒性休克	临床1期	-	The University of North Carolina at Chapel Hill	-
脓毒性休克	临床1期	-	Hibernaid, Inc.	-
脊髓损伤	临床1期	-	Hibernaid, Inc.	-
脊髓损伤	临床1期	-	The University of North Carolina at Chapel Hill	-