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OpenTrials
Completed

NCT Number: NCT01363934

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

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.

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Key information

Conditions

Healthy Volunteer

Age range

20 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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㎝

Treatment and study plan

GC1113

Drug

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 alfa

Drug

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

Primary outcomes

  1. Safety/ Tolerability Evaluation

    Time frame: 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 outcomes

  1. AUClast of GC1113, Cmax of GC1113

    Time frame: Up to 29 days after investigational product administration

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

  2. Immunogenicity of GC1113

    Time frame: Up to 29 days after investigational product administration

    Antibody (GC1113) test

  3. To compare safety and Pharmacokinetics/Pharmacodynamics with active control

    Time frame: Up to 29 days after investigational product administration

    Abdominal Ultrasonograpy, egio genus radiology, blood test, urinalysis, hemoglobin, reticulocyte count, reticulocyte hemoglobin contents

Sponsors and collaborators

Lead sponsor

Green Cross Corporation

Industry

Collaborators

  • Symyoo

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 2, 2011
Registry last updated
Jul 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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