Evaluating Tune-401 for safety and effectiveness in adults with Chronic Hepatitis B
Official title: Phase 1b Multicenter, Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Tune-401 in Participants With Chronic Hepatitis B Infection
Run by Tune Therapeutics, Inc. · NCT06671093 · Data updated 2026-11-12
This study is testing a new drug called Tune-401 to see if it is safe and effective for adults with Chronic Hepatitis B.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 36 (estimated) |
| Sponsor | Tune Therapeutics, Inc. Industry-sponsored |
| Locations | 3 sites (Hong Kong and 2 other locations) |
| Status | Recruiting |
| Started | November 29, 2024 |
| Main results expected | June 28, 2028 |
| Study ends | October 30, 2028 |
| Registry record updated | January 6, 2026 |
| Trial ID | NCT06671093 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18-75 who have been diagnosed with Chronic Hepatitis B and are currently on nucleos(t)ide analogue therapy.
✕Probably not a fit
Patients with liver disease of non-HBV etiology or those with significantly elevated liver enzymes may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This open-label study aims to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of Tune-401 in adults diagnosed with Chronic Hepatitis B. The study will begin with a single-ascending dose phase to determine the appropriate dosage for further evaluation. Following this, an expansion phase will continue to monitor the drug's activity on PD parameters and gather additional safety data. Participants will be closely monitored throughout the study to ensure comprehensive data collection.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients suffering from Chronic Hepatitis B.
How similar studies have gone: Other studies have shown promise with similar approaches in treating Chronic Hepatitis B, but the specific use of Tune-401 is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * M/F, BMI ≥ 18.5 kg/m² at screening, age 18-75, inclusive * Diagnosed with Chronic Hepatitis B * On nucleos(t)ide analogue * HBeAg-negative or positive Exclusion Criteria: * ALT/ AST ≥ 1.5 × upper limit of normal (ULN) and total bilirubin ≥ 1. 5 × ULN * Participants with any evidence or history of liver disease of non-HBV etiology * Other protocol defined Inclusion/Exclusion criteria may apply
Where it's running
-
Queen Mary Hospital, University of Hong Kong
Hong Kong, Hong Kong Recruiting -
PMSI Republican Clinical Hospital "Timofei Mosneaga", Arensia Exploratory Medicine Phase I Unit
Chisinau, Moldova Recruiting -
New Zealand Clinical Research
Auckland, New Zealand Recruiting
Study contacts
- Study coordinator: Tune Therapeutics, Inc.
- Email: clinical.operations@tunetx.com
- Phone: 855 755 8863
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.