NCT01363934

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2011

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

July 19, 2012

Status Verified

July 1, 2012

Enrollment Period

1.1 years

First QC Date

May 31, 2011

Last Update Submit

July 17, 2012

Conditions

Healthy Volunteer

Keywords

ErythropoietinEPO-hFC

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • AUClast of GC1113, Cmax of GC1113

    Up to 29 days after investigational product administration

  • Immunogenicity of GC1113

    Up to 29 days after investigational product administration

  • To compare safety and Pharmacokinetics/Pharmacodynamics with active control

    Up to 29 days after investigational product administration

Study Arms (10)

Group A

EXPERIMENTAL

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

Drug: GC1113

Group B

EXPERIMENTAL

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

Drug: GC1113

Group C

EXPERIMENTAL

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

Drug: GC1113

Group D

EXPERIMENTAL

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

Drug: GC1113

Darbepoetin alfa 30ug/kg by IV

ACTIVE COMPARATOR

Darbepoetin alfa 30ug/kg once intravenously

Drug: Darbepoetin alfa

Group H

EXPERIMENTAL

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

Drug: GC1113

Group I

EXPERIMENTAL

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

Drug: GC1113

Group J

EXPERIMENTAL

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

Drug: GC1113

Group K

EXPERIMENTAL

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

Drug: GC1113

Darbepoetin alfa 30ug/kg by SC

ACTIVE COMPARATOR

Darbepoetin alfa 30ug/kg once subcutaneously

Drug: Darbepoetin alfa

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.

Group AGroup BGroup CGroup DGroup HGroup IGroup JGroup K
Darbepoetin alfaDRUG

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

Darbepoetin alfa 30ug/kg by IVDarbepoetin alfa 30ug/kg by SC

Eligibility Criteria

Age20 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Written informed consent
  • Adult male subjects between 20 to 55 years of age
  • kg ≤ weight ≤ 90kg, 19 ≤ BMI ≤ 27
  • 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

You may not qualify if:

  • 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㎝

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

GC1113Darbepoetin alfa

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Kyung-Sang Yu, MD., Ph.D

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2011

First Posted

June 2, 2011

Study Start

June 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

July 19, 2012

Record last verified: 2012-07