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

Recruiting now · Phase 1

Conditions studied: Chronic Hep B, Chronic Hepatitis b, Chronic Hepatitis, HBV

In brief

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 facts

Study ID

NCT06671093

Run by

Tune Therapeutics, Inc.

People needed

36

Starts

2024-11-29

Expected to finish

2028-10-30

Last updated by the study team

2026-01-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Queen Mary Hospital, University of Hong Kong — Hong Kong, Hong Kong (enrolling)
• PMSI Republican Clinical Hospital "Timofei Mosneaga", Arensia Exploratory Medicine Phase I Unit — Chisinau, Moldova (enrolling)
• New Zealand Clinical Research — Auckland, New Zealand (enrolling)

Full record on ClinicalTrials.gov

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