This is a randomised, double-blind, intravenous single-dose, four-arm parallel study designed to compare the PK of HLX11 and US, EU, and CN-sourced Perjeta® in healthy Chinese adult male subjects, and to assess the safety, tolerability, and immunogenicity of these 4 drugs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
160
healthy volunteers receive HLX11 (420mg) once
healthy volunteers receive CN-Perjeta (420mg) once
healthy volunteers receive EU-Perjeta (420mg) once
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Cmax
Peak concentration
Time frame: from predose to 2352 hours (Day 99),13 timepoints
AUC0~t
Area under the plasma concentration-time curve from time 0 to the last concentration-measurable time point
Time frame: from predose to 2352 hours (Day 99),13 timepoints
AUC0~inf
Area under the plasma concentration-time curve from time 0 to infinity
Time frame: from predose to 2352 hours (Day 99),13 timepoints
safety and tolerability of 4 groups
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: from day1 to day 99
safety and tolerability of 4 groups
Number of AE as assessed by CTCAE v5.0
Time frame: from day1 to day 99
safety and tolerability of two groups
AE listing as assessed by CTCAE v5.0
Time frame: from day1 to day 99
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healthy volunteers receive US-Perjeta (420mg) once