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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06671093




Registration number
NCT06671093
Ethics application status
Date submitted
28/10/2024
Date registered
4/11/2024

Titles & IDs
Public title
Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B
Scientific 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
Secondary ID [1] 0 0
Tune-401-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hep B 0 0
Chronic Hepatitis b 0 0
Chronic Hepatitis 0 0
HBV 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Tune-401

Experimental: Tune-401 SAD 1 - Epigenetic gene silencing system delivered by lipid nanoparticles (LNPs) for intravenous (IV) administration

Experimental: Tune-401 SAD 2 - Epigenetic gene silencing system delivered by lipid nanoparticles (LNPs) for intravenous (IV) administration

Experimental: Tune-401 SAD 3 - Epigenetic gene silencing system delivered by lipid nanoparticles (LNPs) for intravenous (IV) administration

Experimental: Tune-401 Expansion Dose - Epigenetic gene silencing system delivered by lipid nanoparticles (LNPs) for intravenous (IV) administration


Treatment: Other: Tune-401
Epigenetic gene silencing therapy
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety as assessed by treatment emergent adverse events
Timepoint [1] 0 0
20 weeks
Secondary outcome [1] 0 0
Long-term safety
Timepoint [1] 0 0
104 weeks
Secondary outcome [2] 0 0
Tune-401 Pharmacokinetics (Cmax)
Timepoint [2] 0 0
8 weeks
Secondary outcome [3] 0 0
Tune-401 Pharmacokinetics (Tmax)
Timepoint [3] 0 0
8 weeks
Secondary outcome [4] 0 0
Tune-401 Pharmacokinetics (AUC)
Timepoint [4] 0 0
8 weeks
Secondary outcome [5] 0 0
Tune-401 Pharmacokinetics (CL)
Timepoint [5] 0 0
8 weeks
Secondary outcome [6] 0 0
Tune-401 Pharmacokinetics (half-life)
Timepoint [6] 0 0
8 weeks
Secondary outcome [7] 0 0
Tune-401 Pharmacokinetics (Vd)
Timepoint [7] 0 0
8 weeks
Secondary outcome [8] 0 0
Tune-401 Pharmacodynamics
Timepoint [8] 0 0
104 weeks
Secondary outcome [9] 0 0
Tune-401 Immunogenicity
Timepoint [9] 0 0
104 weeks

Eligibility
Key inclusion criteria
* M/F age 18-75, inclusive
* Diagnosed with Chronic Hepatitis B
* On nucleos(t)ide analogue
* HBeAg-negative or positive
* HBsAg > 500 IU/ml
* HBV DNA < 90 IU/ml
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/11/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/10/2028
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Tune Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Tune Therapeutics, Inc.
Address 0 0
Country 0 0
Phone 0 0
855 755 8863
Fax 0 0
Email 0 0
clinical.operations@tunetx.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06671093