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

Phase 1

Recruiting

• Conditions: Chronic Hep B; Chronic Hepatitis b; Chronic Hepatitis; HBV

• Registration Number: NCT06671093
• Lead Sponsor: Tune Therapeutics, Inc.

Brief 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.

Detailed Description

This study consists of an open-label, single-ascending dose phase, which will identify the dose for evaluation in a cohort expansion. The expansion phase will be open-label to further characterize the activity of Tune-401 on PD parameters and obtain additional safety data.

Study Timeline

• Study First Submitted: 2024-10-28
• Study First Submitted QC: 2024-10-31
• Study First Posted: 2024-11-04
• Study Start: 2024-11-29
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-01-27
• Primary Completion: 2028-06-28
• Study Completion: 2028-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• M/F age 18-75, inclusive
• Diagnosed with Chronic Hepatitis B
• On nucleos(t)ide analogue
• HBeAg-negative or positive
• HBsAg > 500 IU/ml
• HBV DNA < 90 IU/ml

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

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Safety as assessed by treatment emergent adverse events	20 weeks	Number of participants with treatment-related adverse events (TEAEs)

Secondary Outcome Measures

Name	Time	Method
Long-term safety	104 weeks	Number of participants with TEAEs ( safety laboratory tests (hematology, biochemistry, coagulation parameters, and urinalysis) and vital signs of clinical significance)
Tune-401 Pharmacokinetics (Cmax)	8 weeks	Maximum concentration (Cmax)
Tune-401 Pharmacokinetics (Tmax)	8 weeks	Time it takes to reach Cmax (Tmax)
Tune-401 Pharmacokinetics (AUC)	8 weeks	Extrapolated area under the concentration-time curve (AUC-infinity)
Tune-401 Pharmacokinetics (CL)	8 weeks	Clearance (CL)
Tune-401 Pharmacokinetics (half-life)	8 weeks	Terminal half-life (t½)
Tune-401 Pharmacokinetics (Vd)	8 weeks	Volume of distribution (Vd)
Tune-401 Pharmacodynamics	104 weeks	Changes from baseline in HBsAg
Tune-401 Immunogenicity	104 weeks	Development of anti-Tune-401 antibodies

Trial Locations

Locations (2)

Queen Mary Hospital, University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong

New Zealand Clinical Research; 🇳🇿 Auckland, New Zealand