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| Name | Class |
|---|---|
| Symyoo | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | GC1113 or Placebo: GC1113 0.3ug/kg to 5ug/kg once intravenously |
|
| Group B | Experimental | GC1113 or Placebo: GC1113 0.3ug/kg to 5ug/kg once intravenously |
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| Group C | Experimental | GC1113 or Placebo: GC1113 0.3ug/kg to 5ug/kg once intravenously |
|
| Group D | Experimental | GC1113 or Placebo: GC1113 0.3ug/kg to 5ug/kg once intravenously |
|
| Darbepoetin alfa 30ug/kg by IV | Active Comparator | Darbepoetin alfa 30ug/kg once intravenously |
|
| Group H | Experimental | GC1113 or Placebo: GC1113 1ug/kg to 8ug/kg once subcutaneously |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GC1113 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| AUClast of GC1113, Cmax of GC1113 | Blood test, urinalysis, hemoglobin, reticulocyte count, reticulocyte hemoglobin contents | Up to 29 days after investigational product administration |
| Immunogenicity of GC1113 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyung-Sang Yu, MD., Ph.D | Seoul National University Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| C000594298 | GC1113 |
| D000068256 | Darbepoetin alfa |
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
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| Group I | Experimental | GC1113 or Placebo: GC1113 1ug/kg to 8ug/kg once subcutaneously |
|
| Group J | Experimental | GC1113 or Placebo: GC1113 1ug/kg to 8ug/kg once subcutaneously |
|
| Group K | Experimental | GC1113 or Placebo: GC1113 1ug/kg to 8ug/kg once subcutaneously |
|
| Darbepoetin alfa 30ug/kg by SC | Active Comparator | Darbepoetin alfa 30ug/kg once subcutaneously |
|
| Darbepoetin alfa | Drug | Each Group volunteers (n=8) will be administered Darbepoetin alfa by IV or SC. |
|
Antibody (GC1113) test
| 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 | Up to 29 days after investigational product administration |
| D002241 |
| Carbohydrates |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |