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

Green Cross Corporation

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: Darbepoetin alfa; Drug: GC1113

Study type: Interventional

Funder types: Industry

Identifiers

NCT01363934

GC1113_P1

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

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㎝

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 10 patient groups

Group A

Experimental group

Description:

GC1113 or Placebo: GC1113 0.3ug/kg to 5ug/kg once intravenously

Treatment:

Drug: GC1113

Group B

Experimental group

Description:

GC1113 or Placebo: GC1113 0.3ug/kg to 5ug/kg once intravenously

Treatment:

Drug: GC1113

Group C

Experimental group

Description:

GC1113 or Placebo: GC1113 0.3ug/kg to 5ug/kg once intravenously

Treatment:

Drug: GC1113

Group D

Experimental group

Description:

GC1113 or Placebo: GC1113 0.3ug/kg to 5ug/kg once intravenously

Treatment:

Drug: GC1113

Darbepoetin alfa 30ug/kg by IV

Active Comparator group

Description:

Darbepoetin alfa 30ug/kg once intravenously

Treatment:

Drug: Darbepoetin alfa

Group H

Experimental group

Description:

GC1113 or Placebo: GC1113 1ug/kg to 8ug/kg once subcutaneously

Treatment:

Drug: GC1113

Group I

Experimental group

Description:

GC1113 or Placebo: GC1113 1ug/kg to 8ug/kg once subcutaneously

Treatment:

Drug: GC1113

Group J

Experimental group

Description:

GC1113 or Placebo: GC1113 1ug/kg to 8ug/kg once subcutaneously

Treatment:

Drug: GC1113

Group K

Experimental group

Description:

GC1113 or Placebo: GC1113 1ug/kg to 8ug/kg once subcutaneously

Treatment:

Drug: GC1113

Darbepoetin alfa 30ug/kg by SC

Active Comparator group

Description:

Darbepoetin alfa 30ug/kg once subcutaneously

Treatment:

Drug: Darbepoetin alfa