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
Location: See all (3) locations...
Intervention Type: Genetic
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Hong Kong Special Administrative Region
Queen Mary Hospital, University of Hong Kong
RECRUITING
Hong Kong
New Zealand
New Zealand Clinical Research
RECRUITING
Auckland
Republic of Moldova
PMSI Republican Clinical Hospital Timofei Mosneaga, Arensia Exploratory Medicine Phase I Unit
RECRUITING
Chisinau
Contact Information
Primary
Tune Therapeutics, Inc.
clinical.operations@tunetx.com
855 755 8863
Time Frame
Start Date: 2024-11-29
Estimated Completion Date: 2028-10-30
Participants
Target number of participants: 36
Treatments
Experimental: Tune-401 Part I : Single Ascending Dose
Epigenetic gene silencing system delivered by lipid nanoparticles (LNPs) for intravenous (IV) administration
Experimental: Tune-401 Part II :Single/Finite Multiple Dose
Epigenetic gene silencing system delivered by lipid nanoparticles (LNPs) for intravenous (IV) administration
Related Therapeutic Areas
Sponsors
Leads: Tune Therapeutics, Inc.