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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: GC1113; Drug: Darbepoetin alfa

• Registration Number: NCT01363934
• Lead Sponsor: Green Cross Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-31
• Study Start: 2011-06
• Study First Submitted QC: 2011-06-01
• Study First Posted: 2011-06-02
• Status Verified: 2012-07
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Last Update Submitted: 2012-07-17
• Last Update Posted: 2012-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 100

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㎝

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	GC1113	GC1113 or Placebo: GC1113 0.3ug/kg to 5ug/kg once intravenously
Group B	GC1113	GC1113 or Placebo: GC1113 0.3ug/kg to 5ug/kg once intravenously
Group C	GC1113	GC1113 or Placebo: GC1113 0.3ug/kg to 5ug/kg once intravenously
Group D	GC1113	GC1113 or Placebo: GC1113 0.3ug/kg to 5ug/kg once intravenously
Darbepoetin alfa 30ug/kg by IV	Darbepoetin alfa	Darbepoetin alfa 30ug/kg once intravenously
Darbepoetin alfa 30ug/kg by SC	Darbepoetin alfa	Darbepoetin alfa 30ug/kg once subcutaneously
Group J	GC1113	GC1113 or Placebo: GC1113 1ug/kg to 8ug/kg once subcutaneously
Group K	GC1113	GC1113 or Placebo: GC1113 1ug/kg to 8ug/kg once subcutaneously
Group H	GC1113	GC1113 or Placebo: GC1113 1ug/kg to 8ug/kg once subcutaneously
Group I	GC1113	GC1113 or Placebo: GC1113 1ug/kg to 8ug/kg once subcutaneously

Primary Outcome Measures

Name	Time	Method
Safety/ Tolerability Evaluation	Up to 29 days after investigational product administration	Number of subjects with Adverse events, Physical examinations, Vital signs, electrocardiogram (ECG), Laboratory tests (including hematology, chemistry, coagulation, urinalysis)

Secondary Outcome Measures

Name	Time	Method
AUClast of GC1113, Cmax of GC1113	Up to 29 days after investigational product administration	Blood test, urinalysis, hemoglobin, reticulocyte count, reticulocyte hemoglobin contents
Immunogenicity of GC1113	Up to 29 days after investigational product administration	Antibody (GC1113) test
To compare safety and Pharmacokinetics/Pharmacodynamics with active control	Up to 29 days after investigational product administration	Abdominal Ultrasonograpy, egio genus radiology, blood test, urinalysis, hemoglobin, reticulocyte count, reticulocyte hemoglobin contents