NCT06671093 Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B
| NCT ID | NCT06671093 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Tune Therapeutics, Inc. |
| Condition | Chronic Hep B |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2024-11-29 |
| Primary Completion | 2028-06-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 36 participants in total. It began in 2024-11-29 with a primary completion date of 2028-06-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will be conducted to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of Tune-401 in adult participants with Chronic Hepatitis B.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06671093 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Chronic Hep B. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06671093 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06671093 currently recruiting?
Yes, NCT06671093 is actively recruiting participants. Contact the research team at clinical.operations@tunetx.com for enrollment information.
Where is the NCT06671093 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong, Chisinau, Moldova, Auckland, New Zealand.
Who is sponsoring the NCT06671093 clinical trial?
NCT06671093 is sponsored by Tune Therapeutics, Inc.. The trial plans to enroll 36 participants.