Healthy VolunteerPhase 1NCT01363934
To Evaluate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Erythropoietin
A Phase 1 study testing GC1113 and Darbepoetin alfa in people with Healthy Volunteer, run by Green Cross Corporation.
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. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- GC1113 and Darbepoetin alfa
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Jul 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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㎝
About this study
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
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.
- Conditions
- Healthy Volunteer
- Being tested
- GC1113, Darbepoetin alfa
- Keywords
- Erythropoietin, EPO-hFC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Darbepoetin alfaDrug
Each Group volunteers (n=8) will be administered Darbepoetin alfa by IV or SC.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | GC1113 or Placebo: GC1113 0.3ug/kg to 5ug/kg once intravenously Receives: Drug: GC1113 |
| Group B | Experimental | GC1113 or Placebo: GC1113 0.3ug/kg to 5ug/kg once intravenously Receives: Drug: GC1113 |
| Group C | Experimental | GC1113 or Placebo: GC1113 0.3ug/kg to 5ug/kg once intravenously Receives: Drug: GC1113 |
| Group D | Experimental | GC1113 or Placebo: GC1113 0.3ug/kg to 5ug/kg once intravenously Receives: Drug: GC1113 |
| Darbepoetin alfa 30ug/kg by IV | Active comparator | Darbepoetin alfa 30ug/kg once intravenously Receives: Drug: Darbepoetin alfa |
| Group H | Experimental | GC1113 or Placebo: GC1113 1ug/kg to 8ug/kg once subcutaneously Receives: Drug: GC1113 |
| Group I | Experimental | GC1113 or Placebo: GC1113 1ug/kg to 8ug/kg once subcutaneously Receives: Drug: GC1113 |
| Group J | Experimental | GC1113 or Placebo: GC1113 1ug/kg to 8ug/kg once subcutaneously Receives: Drug: GC1113 |
| Group K | Experimental | GC1113 or Placebo: GC1113 1ug/kg to 8ug/kg once subcutaneously Receives: Drug: GC1113 |
| Darbepoetin alfa 30ug/kg by SC | Active comparator | Darbepoetin alfa 30ug/kg once subcutaneously Receives: Drug: Darbepoetin alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety/ Tolerability Evaluation
Number of subjects with Adverse events, Physical examinations, Vital signs, electrocardiogram (ECG), Laboratory tests (including hematology, chemistry, coagulation, urinalysis)
Measured: Up to 29 days after investigational product administration
Secondary outcomes (3)
AUClast of GC1113, Cmax of GC1113
Blood test, urinalysis, hemoglobin, reticulocyte count, reticulocyte hemoglobin contents
Measured: Up to 29 days after investigational product administration
Immunogenicity of GC1113
Antibody (GC1113) test
Measured: Up to 29 days after investigational product administration
To compare safety and Pharmacokinetics/Pharmacodynamics with active control
Abdominal Ultrasonograpy, egio genus radiology, blood test, urinalysis, hemoglobin, reticulocyte count, reticulocyte hemoglobin contents
Measured: Up to 29 days after investigational product administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Green Cross Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Symyoo
- Responsible party
- Sponsor
- Investigators
- Kyung-Sang Yu, MD., Ph.D, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01363934
- Sponsor's protocol ID
- GC1113_P1
- Status last verified
- Jul 2012
- First submitted
- 31 May 2011
- Last updated
- 19 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01363934
- Acronym / sponsor ID
- GC1113_P1
- Conditions
- Healthy Volunteer
- Keywords
- Erythropoietin, EPO-hFC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Green Cross CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Symyoo
- Study start
- Jun 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 2 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: GC1113GC1113 or Placebo: GC1113 0.3ug/kg to 5ug/kg once intravenously |
| Group B | Experimental | Drug: GC1113GC1113 or Placebo: GC1113 0.3ug/kg to 5ug/kg once intravenously |
| Group C | Experimental | Drug: GC1113GC1113 or Placebo: GC1113 0.3ug/kg to 5ug/kg once intravenously |
| Group D | Experimental | Drug: GC1113GC1113 or Placebo: GC1113 0.3ug/kg to 5ug/kg once intravenously |
| Darbepoetin alfa 30ug/kg by IV | Active comparator | Drug: Darbepoetin alfaDarbepoetin alfa 30ug/kg once intravenously |
| Group H | Experimental | Drug: GC1113GC1113 or Placebo: GC1113 1ug/kg to 8ug/kg once subcutaneously |
| Group I | Experimental | Drug: GC1113GC1113 or Placebo: GC1113 1ug/kg to 8ug/kg once subcutaneously |
| Group J | Experimental | Drug: GC1113GC1113 or Placebo: GC1113 1ug/kg to 8ug/kg once subcutaneously |
| Group K | Experimental | Drug: GC1113GC1113 or Placebo: GC1113 1ug/kg to 8ug/kg once subcutaneously |
| Darbepoetin alfa 30ug/kg by SC | Active comparator | Drug: Darbepoetin alfaDarbepoetin alfa 30ug/kg once subcutaneously |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GC1113Each 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. | Drug | Group A, Group B, Group C, Group D, Group H, Group I, Group J, Group K |
| Darbepoetin alfaEach Group volunteers (n=8) will be administered Darbepoetin alfa by IV or SC. | Drug | Darbepoetin alfa 30ug/kg by IV, Darbepoetin alfa 30ug/kg by SC |
Primary outcome
Safety/ Tolerability Evaluation
Time frame: 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)
3 secondary outcomes
AUClast of GC1113, Cmax of GC1113
Time frame: Up to 29 days after investigational product administration
Immunogenicity of GC1113
Time frame: Up to 29 days after investigational product administration
To compare safety and Pharmacokinetics/Pharmacodynamics with active control
Time frame: Up to 29 days after investigational product administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2012.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyung-Sang Yu, MD., Ph.D principal investigator
Seoul National University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GC1113 and Darbepoetin alfa in people with Healthy Volunteer, run by Green Cross Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety/ Tolerability Evaluation (time frame: Up to 29 days after investigational product administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2012.