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

Sponsor
Tune Therapeutics, Inc.
Study ID
NCT06671093
Phase
PHASE1
Status
Recruiting
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Conditions

  • Chronic Hep B
  • Chronic Hepatitis
  • Chronic Hepatitis b
  • HBV

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Tune-401 — GENETIC
    Epigenetic gene silencing therapy

Study Details

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.

Key Dates

Start date
Nov 29, 2024
Status verified
Jan 2026
Primary completion
Jun 28, 2028
Completion
Oct 30, 2028

Study Design

Enrollment
36 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Tune-401 Part I : Single Ascending Dose
    Epigenetic gene silencing system delivered by lipid nanoparticles (LNPs) for intravenous (IV) administration
  • Experimental: Tune-401 Part II :Single/Finite Multiple Dose
    Epigenetic gene silencing system delivered by lipid nanoparticles (LNPs) for intravenous (IV) administration

Primary Outcome Measure

Safety as assessed by treatment emergent adverse events [ Time Frame: 20 weeks ]

Central Contacts

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