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Phase I Study GX-G3 in Healthy Subjects (GX-G3)

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ClinicalTrials.gov Identifier: NCT01951027
Recruitment Status : Completed
First Posted : September 26, 2013
Last Update Posted : January 29, 2015
Sponsor:
Information provided by (Responsible Party):
Genexine, Inc.

Brief Summary:
pharmacokinetics/pharmacodynamics of GX-G3 after single subcutaneous administration in healthy male subjects.

Condition or disease Intervention/treatment Phase
Healthy Drug: GX-G3 12.5 μg/kg or Placebo Drug: GX-G3 25 μg/kg or Placebo Drug: GX-G3 50 μg/kg or Placebo Drug: GX-G3 100 μg/kg or Placebo Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Screening
Official Title: A Dose-block Randomized, Double-blind, Placebo-controlled, Dose-escalation Phase I Study to Investigate the Safety, Tolerability, and PK/PD of GX-G3 After Single SC Administration in Healthy Male Subjects
Study Start Date : September 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : December 2014

Arm Intervention/treatment
Experimental: Cohort 1
GX-G3 12.5 μg/kg or Placebo
Drug: GX-G3 12.5 μg/kg or Placebo
Single SC injection
Other Name: GX-G3(G-CSF-hyFc)

Experimental: Cohort 2
GX-G3 25 μg/kg or Placebo
Drug: GX-G3 25 μg/kg or Placebo
Single SC injection
Other Name: GX-G3(G-CSF-hyFc)

Experimental: Cohort 3
GX-G3 50 μg/kg or Placebo
Drug: GX-G3 50 μg/kg or Placebo
Single SC injection
Other Name: GX-G3(G-CSF-hyFc)

Experimental: Cohort 4
GX-G3 100 μg/kg or Placebo
Drug: GX-G3 100 μg/kg or Placebo
Single SC injection
Other Name: GX-G3(G-CSF-hyFc)




Primary Outcome Measures :
  1. DLT incidence and frequency after GX-G3 single S.C. injection [ Time Frame: 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 :
  1. Adverse events incidence and frequency at each dose group after GX-G3 single injection [ Time Frame: 6 weeks ]
  2. Pharmacokinetics parameters after GX-G3 single injection [ Time Frame: 3 weeks ]
    AUC/D, Cmax/D, AUC, AUClast, Cmax, tmax, half-life

  3. Pharmacodynamics parameters after GX-G3 single injection [ Time Frame: 3 weeks ]
    Emax, Emax, Tmax and AUEClast of absolute neutrophil count(ANC), WBC count and CD34+ cell count



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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01951027


Locations
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Korea, Republic of
Chungnam National University Hospital
Jung-gu, Daejeon, Korea, Republic of, 301-721
Sponsors and Collaborators
Genexine, Inc.
Investigators
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Study Director: Sang-In Yang, Ph.D Genexine, Inc, Clinical development Department
Principal Investigator: Jae Woo Kim, M.D. CHUNGNAM NATIONAL UNIVERSITY HOSPITAL Clinical Research Center

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Responsible Party: Genexine, Inc.
ClinicalTrials.gov Identifier: NCT01951027     History of Changes
Other Study ID Numbers: GX-G3_HV_1
First Posted: September 26, 2013    Key Record Dates
Last Update Posted: January 29, 2015
Last Verified: January 2015
Keywords provided by Genexine, Inc.:
Safety
Pharmacokinetics
Pharmacodynamics
DLT
Immunogenecity
Additional relevant MeSH terms:
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Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs