Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B

Tune Therapeutics, Inc.

Status and phase: Enrolling; Phase 1

Conditions: Chronic Hepatitis; Chronic Hepatitis b; Chronic Hep B; HBV

Treatments: Genetic: Tune-401

Study type: Interventional

Funder types: Industry

Identifiers

NCT06671093

Tune-401-001

Details and patient eligibility

About

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.

Full description

This study consists of an open-label, single-ascending dose phase, which will identify the dose for evaluation in a cohort expansion. The expansion phase will be open-label to further characterize the activity of Tune-401 on PD parameters and obtain additional safety data.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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36 participants in 4 patient groups

Tune-401 SAD 1

Experimental group

Description:

Epigenetic gene silencing system delivered by lipid nanoparticles (LNPs) for intravenous (IV) administration

Treatment:

Genetic: Tune-401

Tune-401 SAD 2

Experimental group

Description:

Epigenetic gene silencing system delivered by lipid nanoparticles (LNPs) for intravenous (IV) administration

Treatment:

Genetic: Tune-401

Tune-401 SAD 3

Experimental group

Description:

Epigenetic gene silencing system delivered by lipid nanoparticles (LNPs) for intravenous (IV) administration

Treatment:

Genetic: Tune-401

Tune-401 Expansion Dose

Experimental group

Description:

Epigenetic gene silencing system delivered by lipid nanoparticles (LNPs) for intravenous (IV) administration

Treatment:

Genetic: Tune-401