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

NCT ID: NCT01363934

Last Updated: 2012-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-07-31

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.

Detailed Description

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Conditions

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Healthy Volunteer

Keywords

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Erythropoietin EPO-hFC

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group A

GC1113 or Placebo: GC1113 0.3ug/kg to 5ug/kg once intravenously

Group Type EXPERIMENTAL

GC1113

Intervention Type 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.

Group B

GC1113 or Placebo: GC1113 0.3ug/kg to 5ug/kg once intravenously

Group Type EXPERIMENTAL

GC1113

Intervention Type 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.

Group C

GC1113 or Placebo: GC1113 0.3ug/kg to 5ug/kg once intravenously

Group Type EXPERIMENTAL

GC1113

Intervention Type 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.

Group D

GC1113 or Placebo: GC1113 0.3ug/kg to 5ug/kg once intravenously

Group Type EXPERIMENTAL

GC1113

Intervention Type 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 30ug/kg by IV

Darbepoetin alfa 30ug/kg once intravenously

Group Type ACTIVE_COMPARATOR

Darbepoetin alfa

Intervention Type DRUG

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

Group H

GC1113 or Placebo: GC1113 1ug/kg to 8ug/kg once subcutaneously

Group Type EXPERIMENTAL

GC1113

Intervention Type 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.

Group I

GC1113 or Placebo: GC1113 1ug/kg to 8ug/kg once subcutaneously

Group Type EXPERIMENTAL

GC1113

Intervention Type 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.

Group J

GC1113 or Placebo: GC1113 1ug/kg to 8ug/kg once subcutaneously

Group Type EXPERIMENTAL

GC1113

Intervention Type 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.

Group K

GC1113 or Placebo: GC1113 1ug/kg to 8ug/kg once subcutaneously

Group Type EXPERIMENTAL

GC1113

Intervention Type 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 30ug/kg by SC

Darbepoetin alfa 30ug/kg once subcutaneously

Group Type ACTIVE_COMPARATOR

Darbepoetin alfa

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Darbepoetin alfa

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

Intervention Type DRUG

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㎝
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Symyoo

INDUSTRY

Sponsor Role collaborator

Green Cross Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kyung-Sang Yu, MD., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Countries

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South Korea

Other Identifiers

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GC1113_P1

Identifier Type: -

Identifier Source: org_study_id