NCT07128797

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

A Randomized, Double-Blind, Multi-Center, Placebo-Controlled Phase Ib Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Subcutaneous Injections of B1344 Injection in Patients With Non-Alcoholic Fatty Liver Disease (NAFLD)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Tasly Biopharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• NAFLD (Non-alcoholic Fatty Liver Disease)
• NASH (Nonalcoholic Steatohepatitis)

Interventions

Type	Name	Description
DRUG	B1344	Subcutaneous injection
OTHER	Placebo	Subcutaneous injection

Timeline

• Start date: 2025-07-24
• Primary completion: 2026-06-01
• Completion: 2026-07-01
• First posted: 2025-08-19
• Last updated: 2025-08-19

Locations

5 sites across 1 country: China