drugset
drugset / Trial / NCT07128797

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

NCT07128797 ↗

Phase 1 Recruiting 32 enrolled Tasly Biopharmaceuticals Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2025-07-24
Primary completion
2026-06
Completion
2026-07

Drugs

EvaluationDrugModalityDoseRoute
Subject B1344 Protein / enzyme biologic 30 mg Subcutaneous
Subject B1344 Protein / enzyme biologic 45 mg Subcutaneous
Subject B1344 Protein / enzyme biologic 60 mg Subcutaneous
Subject B1344 Protein / enzyme biologic 90 mg Subcutaneous

Indications

NAFLD1 metabolic dysfunction-associated steatohepatitis