Healthy
Conditions
Keywords
Safety, Pharmacokinetics, Pharmacodynamics, DLT, Immunogenecity
Brief summary
pharmacokinetics/pharmacodynamics of GX-G3 after single subcutaneous administration in healthy male subjects.
Detailed description
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.
Interventions
DRUGGX-G3 12.5 μg/kg or Placebo
Single SC injection
DRUGGX-G3 25 μg/kg or Placebo
Single SC injection
DRUGGX-G3 50 μg/kg or Placebo
Single SC injection
DRUGGX-G3 100 μg/kg or Placebo
Single SC injection
Sponsors
Genexine, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Subjects may be entered in the study only if they meet all of the following criteria: 1. Are capable of understanding and complying with the requirements of the study and have voluntarily signed the informed consent form (ICF); 2. Healthy male volunteers aged 20-45 years; 3. Have a body weight of 60-90 kg (inclusive), have a body mass index (BMI) equal to or greater than 19 and less than 27 kg/m2; 4. Are eligible for the study based on screening data (Subjects may participate if Investigator considered eligible after looking at other screening data);
Exclusion criteria
Subjects presenting with any of the following will not be entered in to the study: 1. Have a history of or current evidence of disease; 2. Have percent of white blood cell (WBC) or neutrophil \> UNL; 3. Have count of platelet \< 100,000/mm3; 4. Have the longest length of spleen \> 16 cm measured by abdomen ultrasonography ; 5. Have MSSBP ≥ 140 mmHg or ≤ 90 mmHg and/or MSDBP ≥ 95 mmHg or ≤ 50 mmHg; (BP must be measured after resting for at least 3 minutes) 6. Have clinically significant arrhythmia by EKG/ECG; 7. Are positive for HBV, HCV, HIV; 8. Have a history of allergy/hypersensitivity or ongoing allergy/hypersensitivity to any drug, as judged by the investigator; 9. Have had any blood donation/ blood loss greater than 400 ml within 8 weeks prior to dosing; 10. Have participated in another clinical trial with investigational drugs within 8 weeks of screening period; 11. Any other conditions that are considered inappropriate or unsafe for subjects by the Investigator; 12. Are considered ineligible by the investigator due to physical findings or laboratory values at the screening assessments; 13. Have a history of G-CSF treatment;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DLT incidence and frequency after GX-G3 single S.C. injection | 6 weeks | \[DLT criteria: CTCAE V4.03\] 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events incidence and frequency at each dose group after GX-G3 single injection | 6 weeks | — |
| Pharmacokinetics parameters after GX-G3 single injection | 3 weeks | AUC/D, Cmax/D, AUC, AUClast, Cmax, tmax, half-life |
| Pharmacodynamics parameters after GX-G3 single injection | 3 weeks | Emax, Emax, Tmax and AUEClast of absolute neutrophil count(ANC), WBC count and CD34+ cell count |
Countries
South Korea
Outcome results
None listed