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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: GC1113; Drug: Darbepoetin alfa

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

10

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Green Cross Corporation
• Collaborators: Symyoo
• Investigators: Principal Investigator: Kyung-Sang Yu, MD., Ph.D, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: May 31, 2011
• First Submitted That Met QC Criteria: June 1, 2011
• First Posted (Estimate): June 2, 2011

Study Record Updates

• Last Update Posted (Estimate): July 19, 2012
• Last Update Submitted That Met QC Criteria: July 17, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Erythropoietin; EPO-hFC
• Additional Relevant MeSH Terms: Hematinics; Darbepoetin alfa
• Other Study ID Numbers: GC1113_P1