RecruitingPhase 1NCT06671093
Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B
Phase 1b Multicenter, Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Tune-401 in Participants With Chronic Hepatitis B Infection
Sponsor
Tune Therapeutics, Inc.
Enrollment
36 participants
Start Date
Nov 29, 2024
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria4
- 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
Exclusion Criteria2
- 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
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Interventions
GENETICTune-401
Epigenetic gene silencing therapy
Locations(3)
View Full Details on ClinicalTrials.gov
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NCT06671093
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