Fu Hong Han Lin (02696) announced that recently, HLX6018 (recombinant anti-GARP/TGF-beta1...
Zhitong Finance App News, Fu Hong Han Lin (02696) announced that recently, the first phase clinical study of HLX6018 (recombinant anti-GARP/TGF-beta1 humanized monoclonal antibody injection) (HLX6018) in healthy subjects completed the first patient administration in China (excluding Hong Kong, Macao and Taiwan regions, same below).
According to reports, this study is a randomized, double-blind, placebo-controlled, single-dose, dose-escalating phase 1 clinical study aimed at evaluating the safety, tolerability, pharmacokinetic characteristics and immunogenicity of HLX6018 in healthy subjects. Eligible subjects will receive intravenous HLX6018 or placebo in different doses (0.25 mg/kg, 1.0 mg/kg, 4.0 mg/kg, 12 mg/kg, 25 mg/kg, 50 mg/kg, 70 mg/kg). Each dose group is intended to enroll subjects with a male to female ratio close to 1:1. After all participants in each dose group complete administration and a 21-day safety observation period, the Safety Assessment Committee (SRC) assesses safety and decides whether to enter the next dose group. Once the pre-set maximum dose (70 mg/kg) is reached, it is up to the SRC to decide whether to explore a higher dose. The main endpoints of this study were safety evaluation, including the number and incidence of adverse events and serious adverse events, vital signs, physical examination, laboratory tests, 12-lead ECG, etc.; secondary endpoints included pharmacokinetic parameters and immunogenicity.
HLX6018 is an innovative anti-GARP/TGF-beta1 complex monoclonal antibody independently developed by the company and intended for the treatment of fibrosis-related diseases. In March 2024, the clinical trial application for HLX6018 for the treatment of idiopathic pulmonary fibrosis was approved by the State Drug Administration.