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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01363934

Enrollment

100

Registered

2011-06-02

Start date

2011-06-30

Completion date

2012-07-31

Last updated

2012-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteer

Keywords

Erythropoietin, EPO-hFC

Brief 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.

Interventions

DRUGGC1113

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.

DRUGDarbepoetin alfa

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

20 Years to 55 Years

Healthy volunteers

Yes

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㎝

Design outcomes

Primary

Measure	Time frame	Description
Safety/ Tolerability Evaluation	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

Measure	Time frame	Description
AUClast of GC1113, Cmax of GC1113	Up to 29 days after investigational product administration	Blood test, urinalysis, hemoglobin, reticulocyte count, reticulocyte hemoglobin contents
Immunogenicity of GC1113	Up to 29 days after investigational product administration	Antibody (GC1113) test
To compare safety and Pharmacokinetics/Pharmacodynamics with active control	Up to 29 days after investigational product administration	Abdominal Ultrasonograpy, egio genus radiology, blood test, urinalysis, hemoglobin, reticulocyte count, reticulocyte hemoglobin contents

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026