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To Evaluate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Erythropoietin

This study has been completed.
Sponsor:
Collaborator:
Symyoo
Information provided by (Responsible Party):
Green Cross Corporation
ClinicalTrials.gov Identifier:
NCT01363934
First received: May 31, 2011
Last updated: July 17, 2012
Last verified: July 2012
History of Changes

May 31, 2011
July 17, 2012
June 2011
July 2012   (final data collection date for primary outcome measure)
Safety/ Tolerability Evaluation [ Time Frame: Up to 29 days after investigational product administration ] [ Designated as safety issue: Yes ]
Number of subjects with Adverse events, Physical examinations, Vital signs, electrocardiogram (ECG), Laboratory tests (including hematology, chemistry, coagulation, urinalysis)
Same as current
Complete list of historical versions of study NCT01363934 on ClinicalTrials.gov Archive Site
  • AUClast of GC1113, Cmax of GC1113 [ Time Frame: Up to 29 days after investigational product administration ] [ Designated as safety issue: Yes ]
    Blood test, urinalysis, hemoglobin, reticulocyte count, reticulocyte hemoglobin contents
  • Immunogenicity of GC1113 [ Time Frame: Up to 29 days after investigational product administration ] [ Designated as safety issue: Yes ]
    Antibody (GC1113) test
  • To compare safety and Pharmacokinetics/Pharmacodynamics with active control [ Time Frame: Up to 29 days after investigational product administration ] [ Designated as safety issue: Yes ]
    Abdominal Ultrasonograpy, egio genus radiology, blood test, urinalysis, hemoglobin, reticulocyte count, reticulocyte hemoglobin contents
Same as current
Not Provided
Not Provided
 
To Evaluate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Erythropoietin
A Dose-Block Randomized, Double-blind Placebo Controlled, Open-label Active Controlled, Dose-escalation Study to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of GC1113 After Single Intravenous/Subcutaneous Administration in Healthy Male Subjects

This is a Dose-Block Randomized, Double-blind Placebo controlled, Open-label Active controlled, Dose-escalation Study to investigate the safety, tolerability, and Pharmacokinetics/Pharmacodynamics of GC1113 after Single Intravenous/Subcutaneous Administration in Healthy Male Subjects.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Healthy Volunteer
  • Drug: GC1113

    Each Group volunteers (n=10) will be administered GC1113 0.3ug/kg to 5ug/kg or Placebo (GC1113:placebo=8:2) once intravenously.

    Each Group volunteers (n=10) will be administered GC1113 1ug/kg to 8ug/kg or Placebo (GC1113:placebo=8:2) once subcutaneously.

  • Drug: Darbepoetin alfa
    Each Group volunteers (n=8) will be administered Darbepoetin alfa by IV or SC.
  • Experimental: Group A
    GC1113 or Placebo: GC1113 0.3ug/kg to 5ug/kg once intravenously
    Intervention: Drug: GC1113
  • Experimental: Group B
    GC1113 or Placebo: GC1113 0.3ug/kg to 5ug/kg once intravenously
    Intervention: Drug: GC1113
  • Experimental: Group C
    GC1113 or Placebo: GC1113 0.3ug/kg to 5ug/kg once intravenously
    Intervention: Drug: GC1113
  • Experimental: Group D
    GC1113 or Placebo: GC1113 0.3ug/kg to 5ug/kg once intravenously
    Intervention: Drug: GC1113
  • Active Comparator: Darbepoetin alfa 30ug/kg by IV
    Darbepoetin alfa 30ug/kg once intravenously
    Intervention: Drug: Darbepoetin alfa
  • Experimental: Group H
    GC1113 or Placebo: GC1113 1ug/kg to 8ug/kg once subcutaneously
    Intervention: Drug: GC1113
  • Experimental: Group I
    GC1113 or Placebo: GC1113 1ug/kg to 8ug/kg once subcutaneously
    Intervention: Drug: GC1113
  • Experimental: Group J
    GC1113 or Placebo: GC1113 1ug/kg to 8ug/kg once subcutaneously
    Intervention: Drug: GC1113
  • Experimental: Group K
    GC1113 or Placebo: GC1113 1ug/kg to 8ug/kg once subcutaneously
    Intervention: Drug: GC1113
  • Active Comparator: Darbepoetin alfa 30ug/kg by SC
    Darbepoetin alfa 30ug/kg once subcutaneously
    Intervention: Drug: Darbepoetin alfa
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
July 2012
July 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Written informed consent
  • Adult male subjects between 20 to 55 years of age
  • 60kg ≤ weight ≤ 90kg, 19 ≤ BMI ≤ 27
  • 12 g/dL ≤ Hemoglobin ≤ 16 g/dL within the 28 days prior to investigational product (IP)injection
  • WBC ≥ 3.0Ⅹ10^9/L, platelet ≥ 140Ⅹ10^9/L within the 28 days prior to IP injection

Exclusion Criteria:

  • Allergic to IP ingredients
  • History of uncontrolled liver, kidney, respiratory, endocrine, neurology, immunology, hematology, mental symptom, circulatory and malignancy disease
  • Prior exposure to EPO, darbepoetin, other EPO, immunoglobulin, IV iron supplementation
  • History of hypersensitivity reaction to EPO, darbepoetin, excipient of IP or hyperergia to iron supplementation
  • Epilepsy within the 6 months prior to IP injection
  • Positivity for HIV antibody, HBsAg, HCV antibody test
  • Spleen length > 16㎝
Male
20 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01363934
GC1113_P1
Yes
Green Cross Corporation
Green Cross Corporation
Symyoo
Principal Investigator: Kyung-Sang Yu, MD., Ph.D Seoul National University Hospital
Green Cross Corporation
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP