Safety of Inhaled Hydrogen Gas Mixtures in Healthy Volunteers

NCT04046211 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: IRB-P00031196
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Adverse effects/symptoms

  Any adverse effects will be codified according the the NCI CTCAE v5.0

  During inhalation exposure

• Adverse effects/symptoms

  Any adverse effects will be codified according the the NCI CTCAE v5.0

  2 hours following end of exposure period

• Adverse effects/symptoms

  Any adverse effects will be codified according the the NCI CTCAE v5.0

  24 hours following end of exposure period

• Adverse effects/symptoms

  Any adverse effects will be codified according the the NCI CTCAE v5.0

  5 days following end of exposure period

Secondary Outcomes (3)

• Change in mini-mental state exam

  1 hour before end of exposure period

• Bedside spirometry

  1 hour before end of exposure period

• Bedside spirometry

  1 hour before end of exposure period

Study Arms (1)

Hydrogen exposure

EXPERIMENTAL

The first two patients will be exposed to 2.4% hydrogen gas in medical air via HFNC for 24 hours. The second two patients will be exposed to the same gas for 48 hours. The final 4 patients will be exposed to the same gas for 72 hours.

Drug: Hydrogen

Interventions

Hydrogen DRUG

Gas exposure for 24, 48 or 72 hours via high flow nasal cannula.

Hydrogen exposure

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Each duration group will be 50% male and 50% female.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 to 35
• Able to remain inpatient for duration of admission (24-72 hours)

You may not qualify if:

• History of any chronic illness, including respiratory disorders such as asthma, chronic obstructive pulmonary disease, prior acute lung injury or acute respiratory distress syndrome;
• Inflammatory disorders, such as lupus erythematosus, inflammatory bowel disease;
• Heritable disorders, such as trisomy 21, cystic fibrosis;
• Mitochondrial disorders;
• Currently smoking cigarettes or have a history of smoking cigarettes;
• The regular use of prescription medications (except for contraceptive medications) within 30 days of enrollment;
• Any lifetime inpatient hospitalization for respiratory illness;
• Pregnancy.

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Cole AR, Perry DA, Raza A, Nedder AP, Pollack E, Regan WL, van den Bosch SJ, Polizzotti BD, Yang E, Davila D, Afacan O, Warfield SK, Ou Y, Sefton B, Everett AD, Neil JJ, Lidov HGW, Mayer JE, Kheir JN. Perioperatively Inhaled Hydrogen Gas Diminishes Neurologic Injury Following Experimental Circulatory Arrest in Swine. JACC Basic Transl Sci. 2019 Mar 27;4(2):176-187. doi: 10.1016/j.jacbts.2018.11.006. eCollection 2019 Apr.

  PMID: 31061920 RESULT

MeSH Terms

Interventions

Hydrogen

Intervention Hierarchy (Ancestors)

Elements; Inorganic Chemicals; Gases

Study Officials

• John Kheir, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Harvard Medical School

Study Record Dates

• First Submitted: July 25, 2019
• First Posted: August 6, 2019
• Study Start: October 26, 2020
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: May 6, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)