Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTune Therapeutics, Inc.
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Tune-401
Treatment groups
36 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov