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Phase 1b Open-Label Study to Evaluate Safety and Effects of Tune-401 in Adults with Chronic Hepatitis B
Led by Tune Therapeutics, Inc. · Updated on 2026-01-06
36
Participants Needed
3
Research Sites
17 weeks
Total Duration
AI-Summary
What This Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics how the drug moves through the body, and pharmacodynamics how the drug affects the body of Tune-401 in adults with Chronic Hepatitis B. This is an open-label Phase 1b study that aims to understand how Tune-401 behaves in the body and its safety profile in this population. The study includes adults aged 18 to 75 who have Chronic Hepatitis B and are currently on nucleostide analogue treatment. The study has two parts Part I involves a single ascending dose of Tune-401, and Part II involves single and finite multiple doses to further characterize the drugs activity and gather safety data. Tune-401 is an epigenetic gene silencing therapy delivered intravenously using lipid nanoparticles. Participants will receive the treatment via IV administration during these phases. Participants will be monitored for treatment-emergent adverse events over 20 weeks to assess safety. Additional long-term safety, pharmacokinetics, pharmacodynamics, and immunogenicity of Tune-401 will be evaluated over up to 104 weeks. The study involves regular assessments to track how the drug is processed by the body and its effects, as well as safety monitoring throughout and after treatment.
CONDITIONS
Brief Title
Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B
Research Team
T
Tune Therapeutics, Inc.
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