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

NCT07128797 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-08-19

No results posted yet for this study

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

DRUG

B1344

Subcutaneous injection

OTHER

Placebo

Subcutaneous injection

Sponsors & Collaborators

  • Tasly Biopharmaceuticals Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-24
Primary Completion
2026-06-30
Completion
2026-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07128797 on ClinicalTrials.gov