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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: GC1113
* Drug: Darbepoetin alfa


Participation Criteria
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Eligibility Criteria
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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㎝

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>GC1113 or Placebo: GC1113 0.3ug/kg to 5ug/kg once intravenously | Drug: GC1113<br>* 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.<br>|
| Experimental: Group B<br>GC1113 or Placebo: GC1113 0.3ug/kg to 5ug/kg once intravenously | Drug: GC1113<br>* 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.<br>|
| Experimental: Group C<br>GC1113 or Placebo: GC1113 0.3ug/kg to 5ug/kg once intravenously | Drug: GC1113<br>* 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.<br>|
| Experimental: Group D<br>GC1113 or Placebo: GC1113 0.3ug/kg to 5ug/kg once intravenously | Drug: GC1113<br>* 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.<br>|
| Active Comparator: Darbepoetin alfa 30ug/kg by IV<br>Darbepoetin alfa 30ug/kg once intravenously | Drug: Darbepoetin alfa<br>* Each Group volunteers (n=8) will be administered Darbepoetin alfa by IV or SC.<br>|
| Experimental: Group H<br>GC1113 or Placebo: GC1113 1ug/kg to 8ug/kg once subcutaneously | Drug: GC1113<br>* 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.<br>|
| Experimental: Group I<br>GC1113 or Placebo: GC1113 1ug/kg to 8ug/kg once subcutaneously | Drug: GC1113<br>* 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.<br>|
| Experimental: Group J<br>GC1113 or Placebo: GC1113 1ug/kg to 8ug/kg once subcutaneously | Drug: GC1113<br>* 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.<br>|
| Experimental: Group K<br>GC1113 or Placebo: GC1113 1ug/kg to 8ug/kg once subcutaneously | Drug: GC1113<br>* 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.<br>|
| Active Comparator: Darbepoetin alfa 30ug/kg by SC<br>Darbepoetin alfa 30ug/kg once subcutaneously | Drug: Darbepoetin alfa<br>* Each Group volunteers (n=8) will be administered Darbepoetin alfa by IV or SC.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Erythropoietin, EPO-hFC