pharmacokinetics/pharmacodynamics of GX-G3 after single subcutaneous administration in healthy male subjects.
MTD will be determined by DLT occurrence and frequency, and severity and charactoristic of adverse event, vital sign, physical examination, ECG, Laboratory test, chest-X-ray will be examined for safety evaluation. The second purpose is to evaluate pharmacokinetics and pharmacodynamics, and immunogenecity will be evaluated to investigate antibody production.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Enrollment
53
Single SC injection
Single SC injection
Single SC injection
Chungnam National University Hospital
Jung-gu, Daejeon, South Korea
DLT incidence and frequency after GX-G3 single S.C. injection
\[DLT criteria: CTCAE V4.03\] 1. Hematologic type: grade 3 Hematologic N.O.S, grade 3 or 4 Leukocytosis 2. Non-Hematologic: grade 3 N.O.S * N.O.S: not otherwise specified * Leukocytosis: continued more than 5 days, grade 3(\>100,000 cells/mm3), or grade 4(clinical manifestations of leucostasis; urgent intervention indicated)
Time frame: 6 weeks
Adverse events incidence and frequency at each dose group after GX-G3 single injection
Time frame: 6 weeks
Pharmacokinetics parameters after GX-G3 single injection
AUC/D, Cmax/D, AUC, AUClast, Cmax, tmax, half-life
Time frame: 3 weeks
Pharmacodynamics parameters after GX-G3 single injection
Emax, Emax, Tmax and AUEClast of absolute neutrophil count(ANC), WBC count and CD34+ cell count
Time frame: 3 weeks
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Single SC injection