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

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

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

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of HM10760A (Long-acting Erythropoietin) in Healthy Adult Caucasian and Japanese Subjects

NCT01030315

Healthy

COMPLETED PHASE1

A Study of HM10760A (Long-acting Erythropoietin (EPO)) in Healthy Korean Subjects

NCT01013064

Healthy

COMPLETED PHASE1

Biosimilarity Study of Intravenous Recombinant Human Erythropoietin in Healthy Volunteers

NCT04954989

Healthy

NOT_YET_RECRUITING PHASE1

A Randomized, Double-blinded, Active Controlled Crossover Clinical Trial to Investigate PK, PD and Safety of GBPD002

NCT05585658

Natural Blood and Blood Product Toxicity

COMPLETED PHASE1/PHASE2

Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Erythropoietic Protoporphyria

NCT03520036

Erythropoietic Protoporphyria (EPP)

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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