Not Yet RecruitingPhase 1

Safety Study of Intravenous Hydrogen-Oxygen Ultrafine Bubbles in Adults

Indonesia50 participantsStarted 2026-05-01

Plain-language 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.

Who can participate

Age range30 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults aged 30 to 60 years at the time of enrollment. * Judged to be healthy or to have mild, stable, well-controlled medical conditions based on medical history, physical examination, vital signs, and screening laboratory assessments. * Body mass index (BMI) within 18.5 to 30.0 kg/m². * Able and willing to comply with all study procedures and scheduled visits. * Able to understand the study procedures and provide written informed consent prior to participation. Exclusion Criteria: * History or presence of clinically significant cardiovascular, pulmonary, neurological, hepatic, renal, hematologic, or immunologic disease that, in the investigator's judgment, could increase risk or interfere with study participation. * Known history of stroke, transient ischemic attack, myocardial infarction, heart failure, or significant arrhythmia. * Active infection, inflammatory condition, or febrile illness within 14 days prior to screening. * Abnormal baseline laboratory findings considered clinically significant by the investigator. * Known hypersensitivity or allergy to components of the investigational infusion or intravenous administration materials. * Current or recent (within 30 days) participation in another interventional clinical study. * Use of investigational drugs or therapies within 30 days prior to enrollment. * Pregnancy or breastfeeding. Women of childbearing potential who are unwilling to use effective contraception during the study period. * Any …

What they're measuring

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Timeframe: From first infusion (Day 0) through approximately 21 days after first infusion.

Number of Participants With Clinically Significant Laboratory Abnormalities

Timeframe: From baseline through approximately 21 days after first infusion.

Trial details

NCT IDNCT07357909

SponsorYayasan Inovasi Molekuler Indonesia (Indonesia Molecular Innovation Foundation)

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11-30

Contact for this trial

Aditya T Hernowo, M.D., Ph.D.

+62 823-2601-7575 hernowo@molecularinnovation.id

View on ClinicalTrials.gov More Healthy Volunteer trials