NCT04046211 is a Phase 1 clinical trial of Hydrogen in Healthy, sponsored by Boston Children's Hospital.

Who is sponsoring NCT04046211?

NCT04046211 is sponsored by Boston Children's Hospital.

What drugs are being tested in NCT04046211?

Interventions in NCT04046211: Hydrogen.

Is NCT04046211 still recruiting?

NCT04046211 is currently completed. Last updated 6 May 2021.

Last reviewed 2021-05-06 · How we verify

NCT04046211

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety of Inhaled Hydrogen Gas Mixtures in Healthy Volunteers

Completed Phase 1 Last updated 6 May 2021

What this trial tests

Phase 1 trial testing Hydrogen in Healthy in 8 participants. Completed in 1 May 2021.

Timeline

26 October 2020

Primary endpoint
1 May 2021

1 May 2021

Quick facts

Lead sponsor	Boston Children's Hospital
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	screening
Enrollment	8
Start date	26 October 2020
Primary completion	1 May 2021
Estimated completion	1 May 2021
Sites	1 location across United States

Drugs / interventions tested

Hydrogen — full drug profile →

Conditions studied

Healthy — all drugs for Healthy →

Sponsor

Boston Children's Hospital

Who can join

Adults 18 to 35, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Molecular Hydrogen Therapy-A Review on Clinical Studies and Outcomes.
Johnsen HM, Hiorth M, Klaveness J. · · 2023 · cited 58× · PMID 38067515 · DOI 10.3390/molecules28237785
Safety of Prolonged Inhalation of Hydrogen Gas in Air in Healthy Adults.
Cole AR, Sperotto F, DiNardo JA, Carlisle S, et al · · 2021 · cited 29× · PMID 34651133 · DOI 10.1097/cce.0000000000000543
Suppression of autophagy facilitates hydrogen gas-mediated lung cancer cell apoptosis.
Liu L, Yan Z, Wang Y, Meng J, et al · · 2020 · cited 10× · PMID 32863925 · DOI 10.3892/ol.2020.11973

Verify or expand the search:

Other trials of Hydrogen

Trials testing the same drug.

NCT05574296 — Hydrogen's Feasibility and Safety as a Therapy in ECPR · Phase 1 · recruiting
NCT05196295 — To Evaluate the Safety of Treating Rheumatologic and Metabolic Patients With Molecular Hydrogen Supplement. · Phase 1 · unknown
NCT05116215 — To Evaluate the Safety of Treating Autoimmune Diseases With Molecular Hydrogen Supplement · Phase 1 · unknown
NCT04175301 — Effect H2 Water on QoL of Patients Receiving Radiotherapy for High Grade Gliomas. · Phase 2 · active not recruiting
NCT03971617 — Clinical Trial to Evaluate the Safety and Tolerability of Hydrogen in Patients With Parkinson's Disease · Phase 2, PHASE3 · terminated

Other recruiting trials for Healthy

Currently open trials in the same condition.

NCT06707207 — Predicting Future Errors During Skill Performance · recruiting
NCT07169630 — PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI) · Phase 1 · recruiting
NCT07499414 — The Effects of the Bile Acid Supplement, 7-keto Lithocholic Acid, on Human Gut Microbiota and Risk Factors for Disease. · NA · recruiting
NCT07496697 — Effects of Electroacupuncture at NP82 and SP15 on Bowel Motility in Healthy Subjects · NA · recruiting
NCT06431932 — Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity · Phase 1, PHASE2 · recruiting

Other Boston Children's Hospital trials

Trials by the same sponsor.

NCT06804382 — Academic Detailing to Optimize PrEP Implementation in Pediatric Primary Care Settings: ADOPT-PrEP · NA · not yet recruiting
NCT05113394 — Preventing Childhood Asthma Using Prophylactic House Dust Mite Allergen Immunotherapy · Phase 2 · withdrawn
NCT06434220 — Effect of Predictive Model on ED Physician Assessments of Patient Disposition · NA · not yet recruiting
NCT07476430 — Readiness Outcomes Affecting Return to Sport 3.0 · NA · not yet recruiting
NCT06706336 — Radon Asthma Intervention Trial · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04046211 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boston Children's Hospital
Last refreshed: 6 May 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04046211.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing