Clinical Research Directory

Safety Study of Intravenous Hydrogen-Oxygen Ultrafine Bubbles in Adults

Sponsor: Yayasan Inovasi Molekuler Indonesia (Indonesia Molecular Innovation Foundation)

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.

Official title: A First-in-Human, Dose-Escalation Study to Evaluate the Safety and Tolerability of Intravenous Hydrogen-Oxygen Ultrafine Bubbles in Adults

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