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NCT04046211 · ClinicalTrials.gov registry record · Phase 1
Safety of Inhaled Hydrogen Gas Mixtures in Healthy Volunteers
A Phase 1 study, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT04046211: Completed Phase 1 study, sponsored by Boston Children's Hospital.
NCT04046211 is a Phase 1 study that has completed, run by Boston Children's Hospital. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04046211, a Phase 1 study, has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
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.
Primary Outcome
Any adverse effects will be codified according the the NCI CTCAE v5.0
Interventions
- DRUG Hydrogen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2020-10-26 |
| Est. Completion | 2021-05-01 |
| Phase | Phase 1 |
What the finished NCT04046211 record still lists
NCT04046211 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which Hydrogen is the first listed.
NCT04046211 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04046211 about?
NCT04046211 is a clinical study titled "Safety of Inhaled Hydrogen Gas Mixtures in Healthy Volunteers". 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 ...
What is the current status of trial NCT04046211?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2020-10-26. Estimated completion is 2021-05-01.
What interventions are being tested in trial NCT04046211?
The interventions under investigation include: Hydrogen (DRUG).
Who is sponsoring clinical trial NCT04046211?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04046211's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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