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Clinical Trials/NCT06671093
NCT06671093
Recruiting
Phase 1

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

Tune Therapeutics, Inc.5 sites in 3 countries36 target enrollmentNovember 29, 2024
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ConditionsChronic Hep BChronic Hepatitis bChronic HepatitisHBV

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Chronic Hep B
Sponsor
Tune Therapeutics, Inc.
Enrollment
36
Locations
5
Primary Endpoint
Safety as assessed by treatment emergent adverse events
Status
Recruiting
Last Updated
3 months ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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, 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.

Registry
clinicaltrials.gov
Start Date
November 29, 2024
End Date
October 30, 2028
Last Updated
3 months ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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 Criteria

  • •ALT/ AST ≥ 1.5 × upper limit of normal (ULN) and total bilirubin ≥
  • •Participants with any evidence or history of liver disease of non-HBV etiology
  • •Other protocol defined Inclusion/Exclusion criteria may apply

Outcomes

Primary Outcomes

Safety as assessed by treatment emergent adverse events

Time Frame: 20 weeks

Number of participants with treatment-related adverse events (TEAEs)

Secondary Outcomes

  • Long-term safety(104 weeks)
  • Tune-401 Pharmacokinetics (Cmax)(8 weeks)
  • Tune-401 Pharmacokinetics (Tmax)(8 weeks)
  • Tune-401 Pharmacokinetics (AUC)(8 weeks)
  • Tune-401 Pharmacokinetics (CL)(8 weeks)
  • Tune-401 Pharmacokinetics (half-life)(8 weeks)
  • Tune-401 Pharmacokinetics (Vd)(8 weeks)
  • Tune-401 Pharmacodynamics(104 weeks)
  • Tune-401 Immunogenicity(104 weeks)

Study Sites (5)

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