Clinical Trial

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

Completed Phase 1
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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.
Trial Details
NCT Number NCT07515209
Lead Sponsor Huahui Health
Conditions Chronic Hepatitis B Virus Infection
Enrollment 36 participants
Start Date 2024-12-20
Primary Completion 2025-12-15 (estimated)
Study Completion 2025-12-15 (estimated)
Updated on ClinicalTrials.gov 2026-04-07