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Safety of Inhaled Hydrogen Gas Mixtures in Healthy Volunteers

NCT04046211 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2021-05-06

No results posted yet for this study

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

Interventions

DRUG

Hydrogen

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

Sponsors & Collaborators

Principal Investigators

  • John Kheir, MD · Boston Children's Hospital

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-26
Primary Completion
2021-05-01
Completion
2021-05-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT04046211 on ClinicalTrials.gov