Actively Recruiting
Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B
Led by Tune Therapeutics, Inc. · Updated on 2026-01-06
36
Participants Needed
3
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female with BMI 18.5 kg/m8 or higher at screening
- Age between 18 and 75 years inclusive
- Diagnosed with Chronic Hepatitis B
- Currently on nucleos(t)ide analogue treatment
- HBeAg-negative or HBeAg-positive status
You will not qualify if you...
- ALT or AST levels 1.5 times or higher above the upper limit of normal
- Total bilirubin 1.5 times or higher above the upper limit of normal
- History or evidence of liver disease not caused by Hepatitis B
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Queen Mary Hospital, University of Hong Kong
Hong Kong, Hong Kong
Actively Recruiting
2
PMSI Republican Clinical Hospital "Timofei Mosneaga", Arensia Exploratory Medicine Phase I Unit
Chisinau, Moldova, MD2025
Actively Recruiting
3
New Zealand Clinical Research
Auckland, New Zealand, 1010
Actively Recruiting
Research Team
T
Tune Therapeutics, Inc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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