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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
Tune-401
GeneticEpigenetic gene silencing therapy
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: Tune-401 Part I : Single Ascending DoseExperimental treatment 1 intervention
Group B: Tune-401 Part II :Single/Finite Multiple DoseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety as assessed by treatment emergent adverse events
Number of participants with treatment-related adverse events (TEAEs)
Time frame
20 weeksSecondary outcomes
1
Long-term safety
Number of participants with TEAEs ( safety laboratory tests (hematology, biochemistry, coagulation parameters, and urinalysis) and vital signs of clinical significance)
Time frame
104 weeks2
Tune-401 Pharmacokinetics (Cmax)
Maximum concentration (Cmax)
Time frame
8 weeks3
Tune-401 Pharmacokinetics (Tmax)
Time it takes to reach Cmax (Tmax)
Time frame
8 weeks4
Tune-401 Pharmacokinetics (AUC)
Extrapolated area under the concentration-time curve (AUC-infinity)
Time frame
8 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov