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

RECRUITINGPhase 1Sponsored by Tune Therapeutics, Inc.
Actively Recruiting
PhasePhase 1
SponsorTune Therapeutics, Inc.
Started2024-11-29
Est. completion2028-06-28
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06671093

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

Age: 18 Years – 75 YearsHealthy volunteers accepted
Inclusion Criteria:

* 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 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

Conditions5

Chronic Hep BChronic HepatitisChronic Hepatitis bHBVLiver Disease

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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