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

Healthy Volunteer Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01363934
• Other study ID #: GC1113_P1
• Status: Completed
• Phase: Phase 1
• First received: May 31, 2011
• Last updated: July 17, 2012
• Start date: June 2011
• Est. completion date: July 2012

Study information

• Verified date: July 2012
• Source: Green Cross Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

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 = 3.0?10^9/L, platelet = 140?10^9/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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Green Cross Corporation	Symyoo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	AUClast of GC1113, Cmax of GC1113	Blood test, urinalysis, hemoglobin, reticulocyte count, reticulocyte hemoglobin contents	Up to 29 days after investigational product administration	Yes
Secondary	Immunogenicity of GC1113	Antibody (GC1113) test	Up to 29 days after investigational product administration	Yes
Secondary	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	Yes