The primary objective is to assess the safety of a single dose of GB221 compared to Herceptin® when administered as a single IV injection at a dose of 8 mg/kg. The secondary objective of the study is to assess the pharmacokinetics of GB221 compared to Herceptin®.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
32
The single intravenous infusion of 8mg/kg Coprelotamab shall be administered within 90 minutes through infusion pump.
The single intravenous infusion of 8mg/kgTrastuzumab shall be administered within 90 minutes through infusion pump.
Linear Clinical Research Limited
Nedlands, Western Australia, Australia
physical examination
physical examination
Time frame: Up to 84 days
adverse event
adverse event
Time frame: Up to 84 days
blood pressure
blood pressure
Time frame: Up to 84 days
heart rate
heart rate
Time frame: Up to 84 days
respiration rate
respiration rate
Time frame: Up to 84 days
oxygen saturation
oxygen saturation
Time frame: Up to 84 days
temperature
temperature
Time frame: Up to 84 days
C max
C max
Time frame: Up to 84 days
t max
t max
Time frame: Up to 84 days
AUC
AUC
Time frame: Up to 84 days
CL
CL
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Time frame: Up to 84 days
t ½
t ½
Time frame: Up to 84 days
V
V
Time frame: Up to 84 days