Last reviewed · How we verify
NCT06671093
Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B
Phase 1 trial testing Tune-401 in Chronic Hep B in 36 participants. Currently enrolling.
28 June 2028
Quick facts
| Lead sponsor | Tune Therapeutics, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 36 |
| Start date | 29 November 2024 |
| Primary completion | 28 June 2028 |
| Estimated completion | 30 October 2028 |
| Sites | 3 locations across Hong Kong, New Zealand, Moldova |
Drugs / interventions tested
- Tune-401
Conditions studied
- Chronic Hep B — all drugs for Chronic Hep B →
- Chronic Hepatitis b — all drugs for Chronic Hepatitis b →
- Chronic Hepatitis — all drugs for Chronic Hepatitis →
- HBV — all drugs for HBV →
Sponsor
Tune Therapeutics, Inc.
Who can join
Adults 18 to 75, any sex, with Chronic Hep B or Chronic Hepatitis b. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Epigenome Engineering Using dCas Systems for Biomedical Applications and Biotechnology: Current Achievements, Opportunities and Challenges.
Kovalev MA, Mamaeva NY, Kristovskiy NV, Feskin PG, et al · · 2025 · cited 8× · PMID 40650152 · DOI 10.3390/ijms26136371 -
Multiplex gene editing suppresses random integration of hepatitis B virus DNA in chronically infected liver.
Slattery S, Huo W, Arif A, Gordon J, et al · · 2026 · PMID 42221546 · DOI 10.1016/j.omtn.2026.102944 -
Visions, expectations, and reservations in epigenetic editing: towards responsible innovation.
van Baalen S, Verra T, Macnaghten P, Bunnik E, et al · · 2026 · PMID 42028095 · DOI 10.1186/s43682-026-00047-5 -
The Future of Epigenetics: Emerging Technologies and Clinical Applications.
Iyer KA, Koynova-Tenchov R, Sasso JM, Thite T, et al · · 2026 · PMID 41852637 · DOI 10.1021/acsptsci.5c00729 -
Current status and challenges of therapeutic targets, novel drugs and delivery systems for hepatitis B: how far to our goal?
Liao Y, Lv F, Zhou M, Shen J, et al · · 2025 · PMID 41613597 · DOI 10.3389/fcimb.2025.1692924
Verify or expand the search:
- PubMed search for NCT06671093
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Chronic Hep B
Currently open trials in the same condition.
- NCT06635694 — naVIGation Invitations Liver surveillANce upTake · active not recruiting
- NCT07137247 — Immune Dynamics in the Natural History of Chronic HBV Infection · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06671093 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Tune Therapeutics, Inc.
- Last refreshed: 6 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06671093.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing