Evaluating Tune-401 for safety and effectiveness in adults with Chronic Hepatitis B
Phase 1b Multicenter, Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Tune-401 in Participants With Chronic Hepatitis B Infection
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 |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Tune Therapeutics, Inc. Industry-sponsored |
| Locations | 3 sites (Hong Kong and 2 other locations) |
| Trial ID | NCT06671093 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with liver disease of non-HBV etiology or those with significantly elevated liver enzymes may not benefit from this study.
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 performed: Other studies have shown promise with similar approaches in treating Chronic Hepatitis B, but the specific use of Tune-401 is novel.
Eligibility criteria
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 this trial is running
Hong Kong and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.