Clinical Trial

a Safety, Tolerability, and Pharmacokinetic Trial of Multiple Subcutaneous Injections of B1344 Injection in Patients With Nonalcoholic Fatty Liver Disease（NAFLD）

Recruiting Phase 1
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Record status
This record was last updated August 19, 2025 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.
Summary
This is a randomized, double-blind, multicenter, placebo-controlled, multiple-dose escalating clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity profile of B1344 in patients with NAFLD. Additionally, the trial will conduct preliminary observations on the efficacy of B1344, aiming to provide early proof of concept for B1344 as a therapeutic agent for NASH.
Trial Details
NCT Number NCT07128797
Lead Sponsor Tasly Biopharmaceuticals Co., Ltd.
Conditions NAFLD (Non-alcoholic Fatty Liver Disease), NASH (Nonalcoholic Steatohepatitis)
Enrollment 32 participants
Start Date 2025-07-24
Primary Completion 2026-06 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2025-08-19