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Safety Study of Intravenous Hydrogen-Oxygen Ultrafine Bubbles in Adults

NCT07357909 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-03-27

No results posted yet for this study

Summary

The goal of this clinical trial is to learn whether hydrogen-oxygen ultrafine bubbles can be safely given through a vein (intravenous infusion) to adults. This is a first-in-human study, meaning this type of infusion has not been tested in people before. The study focuses on safety and does not aim to treat or prevent any disease.

The main questions this study aims to answer are: 1) Can hydrogen-oxygen ultrafine bubbles be given safely without causing serious or unacceptable side effects? 2) What dose range can be given safely to adults for future research?

About 40 adult participants, including healthy volunteers or people with mild, stable health conditions, will take part in the study. Each participant will receive two intravenous infusions, given one week apart. Some participants will receive a higher dose during the second infusion, depending on their assigned study group.

Researchers will closely monitor participants before, during, and after each infusion. This includes checking vital signs, heart activity, and blood tests. The study will also collect exploratory laboratory measurements, such as markers related to oxygen levels and oxidative stress, to help guide the design of future studies.

Participants will be followed for safety for about three weeks after starting the study. The information gained from this research will help determine whether hydrogen-oxygen ultrafine bubbles can be studied further in clinical research.

Conditions

  • Healthy Volunteer

Interventions

OTHER

Hydrogen-Oxygen Ultrafine Bubbles

Hydrogen-oxygen ultrafine bubbles are administered as an intravenous infusion using standard clinical infusion equipment. Participants receive two infusions given one week apart according to the assigned dose cohort. Dose escalation across cohorts is guided by predefined safety review criteria.

Sponsors & Collaborators

  • PT Raho Noble Corp

    collaborator UNKNOWN

  • Yayasan Inovasi Molekuler Indonesia (Indonesia Molecular Innovation Foundation)

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
30 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2026-11-30
Completion
2026-12-31

Countries

  • Indonesia

Study Locations

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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 NCT07357909 on ClinicalTrials.gov