This is a randomized, double-blind, parallel three-arm, and single-dose Phase I clinical study, designed to compare the similarity of pharmacokinetics, safety and immunogenicity between BAT2506 Injection and Simponi® (EU-licensed and US-licensed) after single subcutaneous administration in healthy Chinese male subjects.
This is a randomized, double-blind, parallel three-arm, and single-dose Phase I clinical study, designed to compare the similarity of pharmacokinetics, safety and immunogenicity between BAT2506 Injection and Simponi® (EU-licensed and US-licensed) after single subcutaneous administration in healthy Chinese male subjects. The study planes to enroll 375 healthy male subjects who will be randomly assigned to the BAT2506 Injection group, Simponi® (EU-licensed) or Simponi® (US-licensed) groups in a 1:1:1 ratio to receive a single subcutaneous injection of 50 mg BAT2506 Injection or Simponi® (EU-licensed or US-licensed).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
375
50 mg, subcutaneous administration
50 mg, subcutaneous administration
50 mg, subcutaneous administration
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
Cmax
Peak plasma concentration
Time frame: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
AUC0-∞
area under the drug concentration-time curve
Time frame: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
(AUC0-t)
Area under the drug concentration-time curve from time 0 to the last quantifiable data point
Time frame: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
temperature
number of participants with abnormal temperature findings
Time frame: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
pulse
number of participants with abnormal pulse findings
Time frame: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
blood pressure
number of participants with abnormal blood pressure findings
Time frame: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
skin mucosa
number of participants with abnormal skin mucosa findings
Time frame: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
lymph nodes
number of participants with abnormal lymph nodes findings
Time frame: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
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head and neck
number of participants with abnormal head and neck findings
Time frame: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
chest
number of participants with abnormal chest findings
Time frame: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
abdomen
number of participants with abnormal abdomen findings
Time frame: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
spine/extremities
number of participants with abnormal spine/extremities findings
Time frame: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
heart rate
number of participants with abnormal heart rate findings
Time frame: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
PR Interval
number of participants with abnormal PR Interval findings
Time frame: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
RR Interval
number of participants with abnormal RR Interval findings
Time frame: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
QRS Interval
number of participants with abnormal QRS Interval findings
Time frame: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
QT Interval
number of participants with abnormal QT Interval findings
Time frame: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
QTc interval
number of participants with abnormal QTc Interval findings
Time frame: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
hematology,
Number of participants with abnormal hematology findings
Time frame: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
biochemistry
Number of participants with abnormal biochemistry findings
Time frame: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
coagulation routine
Number of participants with abnormal coagulation routine findings
Time frame: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
urinalysis
Number of participants with abnormal urinalysis findings
Time frame: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
Injection-site reaction Injection-site reaction
Injection-site reaction Adverse events (AE), serious adverse events (SAE), etc.
Time frame: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78
Adverse events (AE)
Adverse events (AE), serious adverse events (SAE)
Time frame: on Day1,2,3,4,5,6, 7, 8, 9, 15, 22, 29, 36, 43, 50, 57, 64, and 78