Healthy VolunteerPhase 1NANO-SAFENCT07357909
Safety Study of Intravenous Hydrogen-Oxygen Ultrafine Bubbles in Adults
A Phase 1 study testing Hydrogen-Oxygen Ultrafine Bubbles in people with Healthy Volunteer, run by Yayasan Inovasi Molekuler Indonesia (Indonesia Molecular Innovation Foundation) at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- Hydrogen-Oxygen Ultrafine Bubbles
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 May 2026to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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 condition that, in the investigator's opinion, would make participation unsafe or compromise interpretation of study results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site
Ben Mari Hospital
Malang, East Java, 60217
Aditya T Hernowo, M.D., Ph.D., +62 823-2601-7575, hernowo@molecularinnovation.id
Olly Indrajani, M.D., Ph.D.
About this study
Official title: A First-in-Human, Dose-Escalation Study to Evaluate the Safety and Tolerability of Intravenous Hydrogen-Oxygen Ultrafine Bubbles in Adults
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?
Read more
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.
Read the detailed description
Hydrogen-oxygen ultrafine bubbles (UFB-HHO) are a novel gas-liquid formulation designed to deliver molecular hydrogen and oxygen in the form of nanoscale bubbles suspended in an aqueous solution. While molecular hydrogen administered by inhalation has been investigated in prior clinical and preclinical studies, the intravenous administration of hydrogen-oxygen ultrafine bubbles has not previously been evaluated in humans. Preclinical investigations conducted by the study investigators in animal models have demonstrated the feasibility of intravenous UFB-HHO administration and have not identified acute safety concerns at the dose ranges planned for initial human evaluation, supporting progression to a first-in-human clinical study.
This study is designed as a first-in-human, single-blind, dose-escalation clinical trial to characterize the safety, tolerability, and acceptable dose range of intravenously administered UFB-HHO in adults. The study follows a predefined, safety-review-guided cohort progression strategy, with dose advancement contingent on review of accumulated safety data by a study safety review committee. The primary intent of this study is safety evaluation; it is not designed to assess clinical efficacy.
Participants will receive two intravenous administrations of UFB-HHO, administered one week apart, according to the assigned dose cohort. A sentinel cohort is included to provide early safety confirmation at the lowest planned dose prior to enrollment of subsequent dose-escalation cohorts. Following the sentinel phase, sequential cohorts will evaluate higher second-dose levels while maintaining a consistent initial dose, allowing assessment of tolerability with within-participant dose escalation. This approach is intended to minimize risk while enabling efficient characterization of dose-related safety findings.
Intravenous infusions will be administered using standard clinical infusion equipment at a controlled infusion rate. Participants will undergo structured safety monitoring before, during, and after each infusion. Safety evaluations include clinical observation, vital sign measurements, electrocardiographic monitoring, and laboratory testing. Particular attention is given to infusion-related reactions, cardiopulmonary parameters, and laboratory indicators relevant to hematologic, hepatic, renal, coagulation, inflammatory, hemolytic, and complement activation pathways.
In addition to safety monitoring, the study incorporates exploratory physiological and biochemical assessments intended to characterize biological responses associated with UFB-HHO administration. These exploratory evaluations include measurements related to tissue oxygenation, oxidative stress, and metabolic indicators. Data from these assessments are intended to support dose selection and inform the design of subsequent clinical studies; they are not intended to establish clinical efficacy.
Participant follow-up includes scheduled safety assessments after each infusion and continued observation following completion of dosing to identify any delayed or resolving adverse events. The overall study duration per participant is approximately three weeks from first infusion to completion of planned safety follow-up, with additional follow-up conducted as needed for unresolved safety findings.
The results of this study are expected to define a recommended dose range of UFB-HHO suitable for further clinical investigation and to provide foundational human safety data to support future studies of this investigational platform.
- Conditions
- Healthy Volunteer
- Being tested
- Hydrogen-Oxygen Ultrafine Bubbles
- Keywords
- Hydrogen oxygen nanobubbles, Intravenous infusion, First-in-human study, Dose escalation, Safety, Tolerability, Healthy volunteers, Oxidative stress biomarkers, Tissue oxygenation, Redox biology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrogen-Oxygen Ultrafine BubblesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Intravenous Hydrogen-Oxygen Ultrafine Bubbles | Experimental | Participants in this single-arm study receive intravenous hydrogen-oxygen ultrafine bubbles. The intervention is administered in two infusions given one week apart. Dose escalation is implemented across sequential cohorts based on review of accumulated safety data. Receives: Other: Hydrogen-Oxygen Ultrafine Bubbles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Number and proportion of participants who experience one or more treatment-emergent adverse events following intravenous administration of hydrogen-oxygen ultrafine bubbles. Adverse events will be assessed for severity, seriousness, and relationship to the investigational intervention.
Measured: From first infusion (Day 0) through approximately 21 days after first infusion.
Number of Participants With Clinically Significant Laboratory Abnormalities
Number of participants with laboratory test results that meet predefined criteria for clinically significant abnormalities following administration of hydrogen-oxygen ultrafine bubbles. Laboratory assessments include hematology, renal function, hepatic function, coagulation parameters, markers of hemolysis, inflammatory markers, and complement activation markers.
Measured: From baseline through approximately 21 days after first infusion.
Secondary outcomes (3)
Change From Baseline in Oxidative Stress Biomarker: Malondialdehyde (MDA)
Change from baseline in blood malondialdehyde (MDA) concentration following intravenous administration of hydrogen-oxygen ultrafine bubbles. MDA is used as a biomarker of lipid peroxidation and oxidative stress.
Measured: From baseline through approximately 21 days after first infusion.
Change From Baseline in Antioxidant Enzyme Activity: Superoxide Dismutase (SOD)
Change from baseline in superoxide dismutase (SOD) activity measured in blood samples following administration of hydrogen-oxygen ultrafine bubbles.
Measured: From baseline through approximately 21 days after first infusion.
Change From Baseline in Nuclear Factor Erythroid 2-Related Factor 2 (Nrf2)-Related Biomarker Levels
Change from baseline in circulating Nrf2-related biomarker levels as an exploratory indicator of redox pathway activation following administration of hydrogen-oxygen ultrafine bubbles.
Measured: From baseline through approximately 21 days after first infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start1 May 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- This is a sequential, dose-escalation study in which participants are enrolled in predefined cohorts. An initial sentinel cohort receives the lowest planned dose to confirm safety. Subsequent cohorts are enrolled sequentially and receive higher dose levels based on review of accumulated safety data from preceding cohorts. Dose escalation and cohort progression are guided by predefined safety review criteria. All participants receive the investigational intervention according to their assigned cohort, with structured safety monitoring following each administration.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yayasan Inovasi Molekuler Indonesia (Indonesia Molecular Innovation Foundation)
- Sponsor type
- University, hospital or other
- Collaborators
- PT Raho Noble Corp
- Responsible party
- Principal investigator, Olly Indrajani Dewi, Yayasan Inovasi Molekuler Indonesia (Indonesia Molecular Innovation Foundation)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07357909
- Sponsor's protocol ID
- IMIF-202512-SiGNA-HHO-FIH
- Acronym
- NANO-SAFE
- Status last verified
- Mar 2026
- First submitted
- 30 Dec 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly. De-identified data may be used for internal analyses and future research planning in accordance with applicable ethical approvals and data protection regulations.
Publications
Hernowo, A. T., Widyarti, S., & Aristyani, S. (2024). Evaluating the safety and therapeutic efficacy of intravenous hydrogen nanobubble infusions in a hypercholesterolemic rat model. Berkala Penelitian Hayati, 30(1), 40-47.
Aulanni'am, A., Riawan, W., Dyah Kinasih, W., Sri Widyarti, S., & Olly Indrayani, P. (2025). Uji Toksisitas Gelembung Nano Gasotransmitter. Institut Molekul Indonesia.
Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583.
PubMed 23295957Agustin V, Hernowo A. Stability evaluation of oxyhydrogen and hydrogen nanobubbles under thermal and pH stress conditions. Sci Rep. 2025 Dec 22;15(1):44273. doi: 10.1038/s41598-025-27868-z.
PubMed 41430413Food and Drug Administration, HHS. International Conference on Harmonisation; Guidance on M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals; availability. Notice. Fed Regist. 2010 Jan 21;75(13):3471-2.
PubMed 20349552Ohsawa I, Ishikawa M, Takahashi K, Watanabe M, Nishimaki K, Yamagata K, Katsura K, Katayama Y, Asoh S, Ohta S. Hydrogen acts as a therapeutic antioxidant by selectively reducing cytotoxic oxygen radicals. Nat Med. 2007 Jun;13(6):688-94. doi: 10.1038/nm1577. Epub 2007 May 7.
PubMed 17486089Ichihara M, Sobue S, Ito M, Ito M, Hirayama M, Ohno K. Beneficial biological effects and the underlying mechanisms of molecular hydrogen - comprehensive review of 321 original articles. Med Gas Res. 2015 Oct 19;5:12. doi: 10.1186/s13618-015-0035-1. eCollection 2015.
PubMed 26483953Agarwal A, Ng WJ, Liu Y. Principle and applications of microbubble and nanobubble technology for water treatment. Chemosphere. 2011 Aug;84(9):1175-80. doi: 10.1016/j.chemosphere.2011.05.054.
PubMed 21689840Szebeni J. Complement activation-related pseudoallergy caused by amphiphilic drug carriers: the role of lipoproteins. Curr Drug Deliv. 2005 Oct;2(4):443-9. doi: 10.2174/156720105774370212.
PubMed 16305447Szebeni J. Complement activation-related pseudoallergy: a new class of drug-induced acute immune toxicity. Toxicology. 2005 Dec 15;216(2-3):106-21. doi: 10.1016/j.tox.2005.07.023. Epub 2005 Sep 2.
PubMed 16140450Kensler TW, Wakabayashi N, Biswal S. Cell survival responses to environmental stresses via the Keap1-Nrf2-ARE pathway. Annu Rev Pharmacol Toxicol. 2007;47:89-116. doi: 10.1146/annurev.pharmtox.46.120604.141046.
PubMed 16968214Mattson MP. Hormesis defined. Ageing Res Rev. 2008 Jan;7(1):1-7. doi: 10.1016/j.arr.2007.08.007. Epub 2007 Dec 5.
PubMed 18162444Dragovic RA, Gardiner C, Brooks AS, Tannetta DS, Ferguson DJ, Hole P, Carr B, Redman CW, Harris AL, Dobson PJ, Harrison P, Sargent IL. Sizing and phenotyping of cellular vesicles using Nanoparticle Tracking Analysis. Nanomedicine. 2011 Dec;7(6):780-8. doi: 10.1016/j.nano.2011.04.003. Epub 2011 May 4.
PubMed 21601655
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human, Dose-Escalation Study to Evaluate the Safety and Tolerability of Intravenous Hydrogen-Oxygen Ultrafine Bubbles in Adults
- ClinicalTrials.gov ID
- NCT07357909
- Acronym / sponsor ID
- NANO-SAFE / IMIF-202512-SiGNA-HHO-FIH
- Conditions
- Healthy Volunteer
- Keywords
- Hydrogen oxygen nanobubbles, Intravenous infusion, First-in-human study, Dose escalation, Safety, Tolerability, Healthy volunteers, Oxidative stress biomarkers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Yayasan Inovasi Molekuler Indonesia (Indonesia Molecular Innovation Foundation)University, hospital or other
- Collaborators
- PT Raho Noble Corp
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Hydrogen-oxygen ultrafine bubbles (UFB-HHO) are a novel gas-liquid formulation designed to deliver molecular hydrogen and oxygen in the form of nanoscale bubbles suspended in an aqueous solution. While molecular hydrogen administered by inhalation has been investigated in prior clinical and preclinical studies, the intravenous administration of hydrogen-oxygen ultrafine bubbles has not previously been evaluated in humans. Preclinical investigations conducted by the study investigators in animal models have demonstrated the feasibility of intravenous UFB-HHO administration and have not identified acute safety concerns at the dose ranges planned for initial human evaluation, supporting progression to a first-in-human clinical study.
This study is designed as a first-in-human, single-blind, dose-escalation clinical trial to characterize the safety, tolerability, and acceptable dose range of intravenously administered UFB-HHO in adults. The study follows a predefined, safety-review-guided cohort progression strategy, with dose advancement contingent on review of accumulated safety data by a study safety review committee. The primary intent of this study is safety evaluation; it is not designed to assess clinical efficacy.
Participants will receive two intravenous administrations of UFB-HHO, administered one week apart, according to the assigned dose cohort. A sentinel cohort is included to provide early safety confirmation at the lowest planned dose prior to enrollment of subsequent dose-escalation cohorts. Following the sentinel phase, sequential cohorts will evaluate higher second-dose levels while maintaining a consistent initial dose, allowing assessment of tolerability with within-participant dose escalation. This approach is intended to minimize risk while enabling efficient characterization of dose-related safety findings.
Intravenous infusions will be administered using standard clinical infusion equipment at a controlled infusion rate. Participants will undergo structured safety monitoring before, during, and after each infusion. Safety evaluations include clinical observation, vital sign measurements, electrocardiographic monitoring, and laboratory testing. Particular attention is given to infusion-related reactions, cardiopulmonary parameters, and laboratory indicators relevant to hematologic, hepatic, renal, coagulation, inflammatory, hemolytic, and complement activation pathways.
In addition to safety monitoring, the study incorporates exploratory physiological and biochemical assessments intended to characterize biological responses associated with UFB-HHO administration. These exploratory evaluations include measurements related to tissue oxygenation, oxidative stress, and metabolic indicators. Data from these assessments are intended to support dose selection and inform the design of subsequent clinical studies; they are not intended to establish clinical efficacy.
Participant follow-up includes scheduled safety assessments after each infusion and continued observation following completion of dosing to identify any delayed or resolving adverse events. The overall study duration per participant is approximately three weeks from first infusion to completion of planned safety follow-up, with additional follow-up conducted as needed for unresolved safety findings.
The results of this study are expected to define a recommended dose range of UFB-HHO suitable for further clinical investigation and to provide foundational human safety data to support future studies of this investigational platform.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a sequential, dose-escalation study in which participants are enrolled in predefined cohorts. An initial sentinel cohort receives the lowest planned dose to confirm safety. Subsequent cohorts are enrolled sequentially and receive higher dose levels based on review of accumulated safety data from preceding cohorts. Dose escalation and cohort progression are guided by predefined safety review criteria. All participants receive the investigational intervention according to their assigned cohort, with structured safety monitoring following each administration.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Intravenous Hydrogen-Oxygen Ultrafine Bubbles | Experimental | Other: Hydrogen-Oxygen Ultrafine BubblesParticipants in this single-arm study receive intravenous hydrogen-oxygen ultrafine bubbles. The intervention is administered in two infusions given one week apart. Dose escalation is implemented across sequential cohorts based on review of accumulated safety data. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydrogen-Oxygen Ultrafine BubblesHydrogen-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. | Other | Experimental: Intravenous Hydrogen-Oxygen Ultrafine Bubbles |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: From first infusion (Day 0) through approximately 21 days after first infusion.
Number and proportion of participants who experience one or more treatment-emergent adverse events following intravenous administration of hydrogen-oxygen ultrafine bubbles. Adverse events will be assessed for severity, seriousness, and relationship to the investigational intervention.
Number of Participants With Clinically Significant Laboratory Abnormalities
Time frame: From baseline through approximately 21 days after first infusion.
Number of participants with laboratory test results that meet predefined criteria for clinically significant abnormalities following administration of hydrogen-oxygen ultrafine bubbles. Laboratory assessments include hematology, renal function, hepatic function, coagulation parameters, markers of hemolysis, inflammatory markers, and complement activation markers.
3 secondary outcomes
Change From Baseline in Oxidative Stress Biomarker: Malondialdehyde (MDA)
Time frame: From baseline through approximately 21 days after first infusion.
Change From Baseline in Antioxidant Enzyme Activity: Superoxide Dismutase (SOD)
Time frame: From baseline through approximately 21 days after first infusion.
Change From Baseline in Nuclear Factor Erythroid 2-Related Factor 2 (Nrf2)-Related Biomarker Levels
Time frame: From baseline through approximately 21 days after first infusion.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- BackgroundHernowo, A. T., Widyarti, S., & Aristyani, S. (2024). Evaluating the safety and therapeutic efficacy of intravenous hydrogen nanobubble infusions in a hypercholesterolemic rat model. Berkala Penelitian Hayati, 30(1), 40-47.
- BackgroundAulanni'am, A., Riawan, W., Dyah Kinasih, W., Sri Widyarti, S., & Olly Indrayani, P. (2025). Uji Toksisitas Gelembung Nano Gasotransmitter. Institut Molekul Indonesia.
- Background: PubMed 23295957Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583.
- Background: PubMed 41430413Agustin V, Hernowo A. Stability evaluation of oxyhydrogen and hydrogen nanobubbles under thermal and pH stress conditions. Sci Rep. 2025 Dec 22;15(1):44273. doi: 10.1038/s41598-025-27868-z.
- Background: PubMed 20349552Food and Drug Administration, HHS. International Conference on Harmonisation; Guidance on M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals; availability. Notice. Fed Regist. 2010 Jan 21;75(13):3471-2.
- Background: PubMed 17486089Ohsawa I, Ishikawa M, Takahashi K, Watanabe M, Nishimaki K, Yamagata K, Katsura K, Katayama Y, Asoh S, Ohta S. Hydrogen acts as a therapeutic antioxidant by selectively reducing cytotoxic oxygen radicals. Nat Med. 2007 Jun;13(6):688-94. doi: 10.1038/nm1577. Epub 2007 May 7.
- Background: PubMed 26483953Ichihara M, Sobue S, Ito M, Ito M, Hirayama M, Ohno K. Beneficial biological effects and the underlying mechanisms of molecular hydrogen - comprehensive review of 321 original articles. Med Gas Res. 2015 Oct 19;5:12. doi: 10.1186/s13618-015-0035-1. eCollection 2015.
- Background: PubMed 21689840Agarwal A, Ng WJ, Liu Y. Principle and applications of microbubble and nanobubble technology for water treatment. Chemosphere. 2011 Aug;84(9):1175-80. doi: 10.1016/j.chemosphere.2011.05.054.
- Background: PubMed 16305447Szebeni J. Complement activation-related pseudoallergy caused by amphiphilic drug carriers: the role of lipoproteins. Curr Drug Deliv. 2005 Oct;2(4):443-9. doi: 10.2174/156720105774370212.
- Background: PubMed 16140450Szebeni J. Complement activation-related pseudoallergy: a new class of drug-induced acute immune toxicity. Toxicology. 2005 Dec 15;216(2-3):106-21. doi: 10.1016/j.tox.2005.07.023. Epub 2005 Sep 2.
- Background: PubMed 16968214Kensler TW, Wakabayashi N, Biswal S. Cell survival responses to environmental stresses via the Keap1-Nrf2-ARE pathway. Annu Rev Pharmacol Toxicol. 2007;47:89-116. doi: 10.1146/annurev.pharmtox.46.120604.141046.
- Background: PubMed 18162444Mattson MP. Hormesis defined. Ageing Res Rev. 2008 Jan;7(1):1-7. doi: 10.1016/j.arr.2007.08.007. Epub 2007 Dec 5.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly. De-identified data may be used for internal analyses and future research planning in accordance with applicable ethical approvals and data protection regulations.
Related trials for Healthy Volunteer
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hydrogen-Oxygen Ultrafine Bubbles in people with Healthy Volunteer, run by Yayasan Inovasi Molekuler Indonesia (Indonesia Molecular Innovation Foundation) at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aditya T Hernowo, M.D., Ph.D. (+62 823-2601-7575, hernowo@molecularinnovation.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: From first infusion (Day 0) through approximately 21 days after first infusion.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07357909, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.