NCT06671093

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

Phase 1b Multicenter, Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Tune-401 in Participants With Chronic Hepatitis B Infection

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Tune Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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, 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.

Conditions

• Chronic Hep B
• Chronic Hepatitis b
• Chronic Hepatitis
• HBV

Interventions

Type	Name	Description
GENETIC	Tune-401	Epigenetic gene silencing therapy

Timeline

• Start date: 2024-11-29
• Primary completion: 2028-06-28
• Completion: 2028-10-30
• First posted: 2024-11-04
• Last updated: 2026-01-06

Locations

3 sites across 3 countries: Hong Kong, Moldova, New Zealand

Regulatory

• FDA-regulated drug study