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

Phase

Condition

Hepatitis

Hepatitis B

Hepatitis C; Chronic

Treatment

Tune-401

Clinical Study ID

NCT06671093

Tune-401-001

Ages 18-75
All Genders

Study Summary

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

Inclusion

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

Exclusion Criteria:

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

Study Design

Tune-401

November 29, 2024

October 30, 2028

Study Description

This study consists of an open-label, Part I single-ascending dose phase and Part II single and finite multiple dose phase to characterize the activity of Tune-401 on PD parameters and obtain safety data.

Connect with a study center

Queen Mary Hospital, University of Hong Kong
Hong Kong 1819729,
Hong Kong
Active - Recruiting
PMSI Republican Clinical Hospital "Timofei Mosneaga", Arensia Exploratory Medicine Phase I Unit
Chisinau 618426, MD2025
Moldova
Active - Recruiting
New Zealand Clinical Research
Auckland 2193733, 1010
New Zealand
Active - Recruiting

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