The study consists of 2 parts: Part I study: to preliminarily compare the PK profile of HLX12 and Cyramza This study is an open-label, randomized, parallel-controlled, intravenous single-dose pretrial study comparing the pharmacokinetic profile, safety, tolerability and immunogenicity of HLX12 and Ramucirumab in healthy male adult subjects. The number of subjects is set to 24, who will be randomized into two groups, and each group has the same number of subjects (n=12). Group 1 will receive intravenous infusion of the test preparation T HLX12, while Group 2 will receive Cyramza, once in both groups. Part II study: to compare the PK similarity between HLX12 and Cyramza This study is a randomized, double-blind, parallel-controlled, intravenous single-dose Phase I clinical study comparing the pharmacokinetic profile, safety, tolerability and immunogenicity of HLX12 and Ramucirumab in healthy male adult subjects.The number of subjects is set to 128, and the treatment is the same with Part I study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
24
healthy volunters receive HLX12 (8mg/kg) once
healthy volunters receive Cyramza (Ramucirumab) 8mg/kg once
First Hospital of Jilin University
Changchun, Jilin, China
AUC0~inf
Area under curve from zero to infinity
Time frame: from predose to 1680 hours (Day 71),18 timepoints
safety and tolerability of two groups
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: from day1 to day 71
safety and tolerability of two groups
Number of AE as assessed by CTCAE v5.0
Time frame: from day1 to day 71
safety and tolerability of two groups
AE listing as assessed by CTCAE v5.0
Time frame: from day1 to day 71
AUC0~t
area under the concentration-time curve
Time frame: from predose to 1680 hours (Day 71),18 timepoints
Cmax
maximum concentration
Time frame: from predose to 1680 hours (Day 71),18 timepoints
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