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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
66
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).
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).
First Hospital of Jilin University
Changchun, Jilin, China
The number of subjects experiencing adverse events (AEs) and serious adverse events (SAEs)
Safety evaluation
Time frame: 0 to Day 99
AUC0-inf
Area under the serum concentration-time curve
Time frame: 0 to Day 99
Cmax
Peak concentration
Time frame: 0 to Day 99
Tmax
Time to reach peak concentration
Time frame: 0 to Day 99
T1/2
Terminal elimination half-life
Time frame: 0 to Day 99
CL
Clearance
Time frame: 0 to Day 99
λz
Terminal elimination rate constant
Time frame: 0 to Day 99
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