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drugset / Trial / NCT07515209

A Clinical Study of HH-006 in Untreated Chronic Hepatitis B Virus Infected Patients

NCT07515209 ↗

Phase 1 Completed 36 enrolled Huahui Health
RandomizedParallel-groupTriple-blindTreatment

Summary

This is a randomized, double-blind, placebo-controlled Phase I dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of multiple ascending doses (120 mg, 240 mg, 480 mg SC, QW×5) of HH-006 in untreated chronic HBV patients. Each cohort includes 12 participants (9 active, 3 placebo), with dose progression approved by a Safety Review Committee. Participants are monitored through 24 weeks post-dose. The study design allows for adjustments based on emerging data.

Timeline

Start
2024-12-20
Primary completion
2025-12-15
Completion
2025-12-15

Drugs

EvaluationDrugModalityDoseRoute
Subject HH-006 Monoclonal antibody 120 mg Subcutaneous
Subject HH-006 Monoclonal antibody 240 mg Subcutaneous
Subject HH-006 Monoclonal antibody 480 mg Subcutaneous

Indications

chronic hepatitis B virus infection