Abstract
Introduction: Ischemia reperfusion injury (IRI) is central to many critical illnesses, including cardiac arrest, myocardial infarction, and stroke. Inhaled hydrogen gas (H2) has been shown to diminish IRI in a number of preclinical models, in part by the selective reduction of oxyradical species. Methods: Following FDA and IRB approval of this Investigator-Initiated Phase I IND study (NCT04046211), 8 healthy participants underwent hospitalized exposure to 2.4% H2 in medical air via high flow nasal cannula (15 LPM) for either 24 hours (n=2), 48 hours (n=2), or 72 hours (n=4). Screening for adverse effects included periodic nurse-adjudicated assessments using Common Terminology Criteria for Adverse Events (CTCAE, v5.0); regularly-spaced vital signs, pulmonary function testing, and mini-mental state exam (MMSE); EKG and serologic testing prior to versus following exposure. Data were compared over time using Wilcoxon matched-pairs signed rank test. All AE assignments were verified by two clinicians external to the study team and an external DSMB. Results: Eight adult participants (18-30 years; 50% female; 62% non-Caucasian) completed the study without early termination. No symptoms or clinically significant adverse events occurred in any patient. Compared with baseline measures, there were no significant changes over time in blood pressure, heart rate, oxygen saturation, or respiratory rate (A). There were no significant changes in PFTs (B), MMSE scores (C), EKG measurements (D) or serologic tests for hematologic (except for clinically-insignificant increases in hematocrit and platelet counts), renal, hepatic, pancreatic, or cardiac injury (E) associated with H2 inhalation. Conclusion: Inhalation of 2.4% H2 gas does not appear to cause clinically significant adverse effects in healthy adults. These data will be foundational to future interventional studies of inhaled H2 in injury states, including following cardiac arrest.
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