Phase I Study GX-G3 in Healthy Subjects
- Conditions
- Healthy
- Interventions
- Drug: GX-G3 25 μg/kg or PlaceboDrug: GX-G3 100 μg/kg or PlaceboDrug: GX-G3 50 μg/kg or PlaceboDrug: GX-G3 12.5 μg/kg or Placebo
- Registration Number
- NCT01951027
- Lead Sponsor
- Genexine, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 53
Subjects may be entered in the study only if they meet all of the following criteria:
- Are capable of understanding and complying with the requirements of the study and have voluntarily signed the informed consent form (ICF);
- Healthy male volunteers aged 20-45 years;
- 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;
- Are eligible for the study based on screening data (Subjects may participate if Investigator considered eligible after looking at other screening data);
Subjects presenting with any of the following will not be entered in to the study:
- Have a history of or current evidence of disease;
- Have percent of white blood cell (WBC) or neutrophil > UNL;
- Have count of platelet < 100,000/mm3;
- Have the longest length of spleen > 16 cm measured by abdomen ultrasonography ;
- 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)
- Have clinically significant arrhythmia by EKG/ECG;
- Are positive for HBV, HCV, HIV;
- Have a history of allergy/hypersensitivity or ongoing allergy/hypersensitivity to any drug, as judged by the investigator;
- Have had any blood donation/ blood loss greater than 400 ml within 8 weeks prior to dosing;
- Have participated in another clinical trial with investigational drugs within 8 weeks of screening period;
- Any other conditions that are considered inappropriate or unsafe for subjects by the Investigator;
- Are considered ineligible by the investigator due to physical findings or laboratory values at the screening assessments;
- Have a history of G-CSF treatment;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 2 GX-G3 25 μg/kg or Placebo GX-G3 25 μg/kg or Placebo Cohort 4 GX-G3 100 μg/kg or Placebo GX-G3 100 μg/kg or Placebo Cohort 3 GX-G3 50 μg/kg or Placebo GX-G3 50 μg/kg or Placebo Cohort 1 GX-G3 12.5 μg/kg or Placebo GX-G3 12.5 μg/kg or Placebo
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Pharmacokinetics parameters after GX-G3 single injection 3 weeks AUC/D, Cmax/D, AUC, AUClast, Cmax, tmax, half-life
Adverse events incidence and frequency at each dose group after GX-G3 single injection 6 weeks 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
Trial Locations
- Locations (1)
Chungnam National University Hospital
🇰🇷Jung-gu, Daejeon, Korea, Republic of
Chungnam National University Hospital🇰🇷Jung-gu, Daejeon, Korea, Republic of