Chronic Hep BPhase 1NCT06671093
Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B
A Phase 1 study testing Tune-401 in people with Chronic Hep B and Chronic Hepatitis b, run by Tune Therapeutics, Inc. at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Hep B, Chronic Hepatitis b, Chronic Hepatitis
- What is being tested?
- Tune-401
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 29 Nov 2024to 30 Oct 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
Hong Kong1 site, 1 recruiting
- Recruiting
Queen Mary Hospital, University of Hong Kong
Hong Kong
Man Fung Yuen
Man Fung Yuen, MD
Moldova1 site, 1 recruiting
- Recruiting
PMSI Republican Clinical Hospital "Timofei Mosneaga", Arensia Exploratory Medicine Phase I Unit
Chisinau, MD2025
Alina Jucov
New Zealand1 site, 1 recruiting
- Recruiting
New Zealand Clinical Research
Auckland, 1010
New Zealand Clinical Research, +64 9 373 3474, Rhythm.Auckland@nzcr.co.nz
About this study
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
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.
Read the detailed description
This study consists of an open-label, Part I single-ascending dose phase and Part II single and finite multiple dose phase to characterize the activity of Tune-401 on PD parameters and obtain safety data.
- Conditions
- Chronic Hep B, Chronic Hepatitis b, Chronic Hepatitis, HBV
- Being tested
- Tune-401
- Keywords
- Tune-401, Tune-401-001, CHB
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tune-401Genetic
Epigenetic gene silencing therapy
| Study group | Role | What they receive |
|---|---|---|
| Tune-401 Part I : Single Ascending Dose | Experimental | Epigenetic gene silencing system delivered by lipid nanoparticles (LNPs) for intravenous (IV) administration Receives: Genetic: Tune-401 |
| Tune-401 Part II :Single/Finite Multiple Dose | Experimental | Epigenetic gene silencing system delivered by lipid nanoparticles (LNPs) for intravenous (IV) administration Receives: Genetic: Tune-401 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety as assessed by treatment emergent adverse events
Number of participants with treatment-related adverse events (TEAEs)
Measured: 20 weeks
Secondary outcomes (9)
Long-term safety
Number of participants with TEAEs ( safety laboratory tests (hematology, biochemistry, coagulation parameters, and urinalysis) and vital signs of clinical significance)
Measured: 104 weeks
Tune-401 Pharmacokinetics (Cmax)
Maximum concentration (Cmax)
Measured: 8 weeks
Tune-401 Pharmacokinetics (Tmax)
Time it takes to reach Cmax (Tmax)
Measured: 8 weeks
Tune-401 Pharmacokinetics (AUC)
Extrapolated area under the concentration-time curve (AUC-infinity)
Measured: 8 weeks
Tune-401 Pharmacokinetics (CL)
Clearance (CL)
Measured: 8 weeks
Tune-401 Pharmacokinetics (half-life)
Terminal half-life (t½)
Measured: 8 weeks
Tune-401 Pharmacokinetics (Vd)
Volume of distribution (Vd)
Measured: 8 weeks
Tune-401 Pharmacodynamics
Changes from baseline in HBsAg
Measured: 104 weeks
Tune-401 Immunogenicity
Development of anti-Tune-401 antibodies
Measured: 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start29 Nov 2024
- Primary completion28 Jun 2028 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hep BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tune Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671093
- Sponsor's protocol ID
- Tune-401-001
- Status last verified
- Jan 2026
- First submitted
- 28 Oct 2024
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06671093
- Acronym / sponsor ID
- Tune-401-001
- Conditions
- Chronic Hep B, Chronic Hepatitis b, Chronic Hepatitis, HBV
- Keywords
- Tune-401, Tune-401-001, CHB
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Tune Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Nov 2024 (actual)
- Primary completion
- 28 Jun 2028 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 4 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study consists of an open-label, Part I single-ascending dose phase and Part II single and finite multiple dose phase to characterize the activity of Tune-401 on PD parameters and obtain safety data.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tune-401 Part I : Single Ascending Dose | Experimental | Genetic: Tune-401Epigenetic gene silencing system delivered by lipid nanoparticles (LNPs) for intravenous (IV) administration |
| Tune-401 Part II :Single/Finite Multiple Dose | Experimental | Genetic: Tune-401Epigenetic gene silencing system delivered by lipid nanoparticles (LNPs) for intravenous (IV) administration |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tune-401Epigenetic gene silencing therapy | Genetic | Tune-401 Part I : Single Ascending Dose, Tune-401 Part II :Single/Finite Multiple Dose |
Primary outcome
Safety as assessed by treatment emergent adverse events
Time frame: 20 weeks
Number of participants with treatment-related adverse events (TEAEs)
9 secondary outcomes
Long-term safety
Time frame: 104 weeks
Tune-401 Pharmacokinetics (Cmax)
Time frame: 8 weeks
Tune-401 Pharmacokinetics (Tmax)
Time frame: 8 weeks
Tune-401 Pharmacokinetics (AUC)
Time frame: 8 weeks
Tune-401 Pharmacokinetics (CL)
Time frame: 8 weeks
Tune-401 Pharmacokinetics (half-life)
Time frame: 8 weeks
Tune-401 Pharmacokinetics (Vd)
Time frame: 8 weeks
Tune-401 Pharmacodynamics
Time frame: 104 weeks
Tune-401 Immunogenicity
Time frame: 104 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Hep B
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tune-401 in people with Chronic Hep B and Chronic Hepatitis b, run by Tune Therapeutics, Inc. at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Hong Kong, Moldova, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tune Therapeutics, Inc. (855 755 8863, clinical.operations@tunetx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety as assessed by treatment emergent adverse events (time frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.