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Clinical Trial Summary

The purpose of this study is to investigate the safety, PK, and immunogenicity of a single intravenous administration of HLX6018 in healthy subjects, based on the preliminary efficacy and safety established through in vitro and in vivo experiments. This is a randomized, double-blind, placebo-controlled study with single dose escalation design to assess the safety, PK, and immunogenicity of HLX6018 in healthy subjects. It is planned to enroll 8-10 subjects in each of seven dose groups (0.25 mg/kg, 1.0 mg/kg, 4.0 mg/kg, 12 mg/kg, 25 mg/kg, 50 mg/kg, and 70 mg/kg). This is the first-in-human study of the investigational product.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT06310746
Study type Interventional
Source Shanghai Henlius Biotech
Contact Yanhua Ding
Email dingyanhua2003@126.com
Status Recruiting
Phase Phase 1
Start date April 23, 2024
Completion date December 30, 2026

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