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Phase 1 Study of HBN-1

NCT04094857 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2019-10-07

No results posted yet for this study

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

Interventions

DRUG

HBN-1

Intravenous infusion

Sponsors & Collaborators

  • Hibernaid, Inc

    lead INDUSTRY

Principal Investigators

  • Laurence Katz, MD · Hibernaid, Inc

  • David B Seder, MD · MaineHealth

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-30
Primary Completion
2020-11-01
Completion
2020-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04094857 on ClinicalTrials.gov