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Studies

Interventional Recruiting Phase 1

NCT07128797 on ClinicalTrials.gov

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

Official title: 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)

  • Sponsor: Tasly Pharmaceutical Group Co., Ltd.
  • Enrollment: 32 (Estimated)
  • Study start: 2025-07-24 (Actual)
  • Primary completion: 2026-06-01 (Estimated)
  • Study completion: 2026-07-01 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • PrimaryPurpose: Treatment

Brief 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)

Intervention / Treatment

  • Drug: B1344
  • Other: Placebo

Primary Outcome Measures

  • Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (113 days)

Countries

China

Locations and Investigators

  • Beijing Tsinghua Changgung Hospital (BTCH) affiliated to Tsinghua University, Beijing, China (Recruiting)
    • Lai Wei
  • Nanfang Hospital, Southern Medical University, Guangzhou, China (Not yet recruiting)
    • Jinjun Chen
    • Chongyuan Xu
  • Sinopharm Tongmei General Hospital, Datong, China (Not yet recruiting)
    • Xiujun Li
  • The First Affiliated Hospital to Nankai University, Tianjin, China (Not yet recruiting)
    • Tao Han
  • The First Affiliated Hospital to Wenzhou Medical University, Wenzhou, China (Not yet recruiting)
    • Minghua Zheng