Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B
Recruiting
Phase 1
Interventional Study
Chronic Hep B
Chronic Hepatitis b
Chronic Hepatitis
HBV
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 36 (estimated)
- Sponsor
- Tune Therapeutics, Inc. · Industry
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About This Trial
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.
Trial Locations
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Eligibility Criteria
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 …
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