Safety of Inhaled Hydrogen Gas Mixtures in Healthy Volunteers

• Status: Completed
• Trial end date: 2021-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Boston Children's Hospital; Boston Children’s Hospital

Criteria

Inclusion Criteria:

1. Age 18 to 35

2. Able to remain inpatient for duration of admission (24-72 hours)

Exclusion Criteria:

1. History of any chronic illness, including respiratory disorders such as asthma, chronic obstructive pulmonary disease, prior acute lung injury or acute respiratory distress syndrome;

2. Inflammatory disorders, such as lupus erythematosus, inflammatory bowel disease;

3. Heritable disorders, such as trisomy 21, cystic fibrosis;

4. Mitochondrial disorders;

5. Currently smoking cigarettes or have a history of smoking cigarettes;

6. The regular use of prescription medications (except for contraceptive medications) within 30 days of enrollment;

7. Any lifetime inpatient hospitalization for respiratory illness;

8. Pregnancy.