NCT04046211

Safety of Inhaled Hydrogen Gas Mixtures in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

Hydrogen gas may decrease the degree or incidence of brain injury following ischemia. The purpose of this study is to determine the safety and tolerability of inhaled hydrogen gas at the dose exposures required for a clinical efficacy study in healthy adult participants. Participants will breathe a gas mixture that contains a low concentration of hydrogen gas in air through a high flow nasal cannula. Investigators will test for any changes in breathing and neurologic status, as well as lab tests during and following the exposure period.

Detailed description

Inhaled hydrogen gas (H2) has been shown to have significant protective effects on ischemic organs. Clinical trials abroad have shown promise that treatment of patients suffering from stroke, cardiac arrest, or heart attacks may benefit from inhaling hydrogen gas during the early recovery period. The purpose of this study is to determine the safety and tolerability of inhaled hydrogen gas at the dose exposures required for a clinical efficacy study in healthy adult volunteers. Study design. Eight (8) healthy adult participants will be recruited from the greater Boston area for this study. Consenting participants will be admitted to the hospital and will undergo a series of screens (questionnaires, examination, tests) to ensure suitability to participate. Eligible and consenting participants will then undergo exposure to 2.4% H2 in medical air via high flow nasal cannula for either 24 (n=2), 48 (n=2) or 72 (n=4) hours. Participants will be screened for adverse effects as follows: vital signs every 8 hours, nursing assessment of symptoms (codified based on the National Cancer Institute's Common Terminology Criteria for Adverse Events, CTCAE) every 8 hours, bedside spirometry daily, mini-mental state exam daily, physician physical exam daily, and serum testing (blood count, chemistry, liver and coagulation profile, venous blood gas) following exposure period.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Hydrogen	Gas exposure for 24, 48 or 72 hours via high flow nasal cannula.

Timeline

• Start date: 2020-10-26
• Primary completion: 2021-05-01
• Completion: 2021-05-01
• First posted: 2019-08-06
• Last updated: 2021-05-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study