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

Green Cross Corporation100 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

100

Conditions

Healthy Volunteer

Interventions

GC1113DRUG

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.

Darbepoetin alfaDRUG

Each Group volunteers (n=8) will be administered Darbepoetin alfa by IV or SC.

Eligibility

Sex: MALEMin age: 20 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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㎝

Outcomes

Primary Outcomes

Safety/ Tolerability Evaluation

Number of subjects with Adverse events, Physical examinations, Vital signs, electrocardiogram (ECG), Laboratory tests (including hematology, chemistry, coagulation, urinalysis)

Time frame: Up to 29 days after investigational product administration

Secondary Outcomes

AUClast of GC1113, Cmax of GC1113

Blood test, urinalysis, hemoglobin, reticulocyte count, reticulocyte hemoglobin contents

Time frame: Up to 29 days after investigational product administration

Immunogenicity of GC1113

Antibody (GC1113) test

Time frame: 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

Time frame: Up to 29 days after investigational product administration

Data from ClinicalTrials.gov

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