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| Name | Class |
|---|---|
| Green Cross Corporation | INDUSTRY |
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This study is a four arm, parallel study.
Ten were administered a single subcutaneous administration of 30, 100 and 300 μg/kg of GCPGC or placebo for each group (active:placebo=8:2). Eight were administered a single subcutaneous administration of 100 μg/kg of Neulasta (an active comparator).
Eligibility for participation of this study was determined from demographic information, medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests within 3 weeks before study drug administration. Subjects suitable for this study were admitted to the Clinical Trials Center, Seoul National University Hospital on the day before dosing, and they were overnight-fasted from 10 p.m. of Day -1. Subjects were dosed study drug via subcutaneous around at 9 a.m. of Day 1. Subjects performed scheduled procedures including clinical laboratory tests, electrocardiograms and pharmacokinetic and pharmacodynamic samplings. Subjects were discharged on Day 8, and visited Clinical Trials Center on Day 9, Day 11 and Day 14. Study participation was terminated on post-study visit (Day 20 - 22).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GCPGC 30 μg/kg | Experimental | Ten volunteers were administered GCPGC 30 μg/kg or placebo (active:placebo=8:2) |
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| GCPGC 100 μg/kg | Experimental | Ten volunteers were administered GCPGC 100 μg/kg or placebo (active:placebo=8:2) |
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| GCPGC 300 μg/kg | Experimental | Ten volunteers would be administered GCPGC 300 μg/kg or placebo (active:placebo=8:2) |
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| Neulasta 100 μg/kg | Experimental | Eight volunteers were administered Neulasta 100 μg/kg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GCPGC, Neulasta, Placebo | Drug | A single subcutaneous administration of GCPGC 30 μg/kg, GCPGC 100 μg/kg, GCPGC 300 μg/kg, placebo or Neulasta 100 μg/kg |
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| Measure | Description | Time Frame |
|---|---|---|
| Blood concentration of pegfilgrastim for pharmacokinetics | pre-dose, 3, 6, 9, 12, 24(2d), 36, 48(3d), 72(4d), 96(5d), 120(6d), 144(7d), 168(8d), 192h(9d), 240(11d), 312(14d) |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute Neutrophil Count (ANC) | pre-dose, 6, 12, 24(2d), 48(3d), 72(4d), 96(5d), 120(6d), 144(7d), 168(8d), 192h(9d), 240(11d), 312(14d) | |
| CD34+ Cell count | pre-dose, 6, 12, 24(2d), 48(3d), 72(4d), 96(5d), 120(6d), 144(7d), 168(8d), 192h(9d), 240(11d), 312(14d) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyung-Sang Yu, MD, PhD | Seoul National University College of Medicine and Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trials Center, Seoul National University Hospital | Seoul | 110-744 | South Korea |
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| ID | Term |
|---|---|
| C455861 | pegfilgrastim |
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