drugset / Trial / NCT01363934
To Evaluate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Erythropoietin
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2011-06
- Primary completion
- 2012-07
- Completion
- 2012-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Darbepoetin alfa | Protein / enzyme biologic | 30 ug/kg | Intravenous |
| Subject | GX-E2 | Unknown | 0.3 ug/kg | Intravenous |
| Subject | GX-E2 | Unknown | 1 ug/kg | Intravenous |
| Subject | GX-E2 | Unknown | 5 ug/kg | Intravenous |
| Subject | GX-E2 | Unknown | 8 ug/kg | Intravenous |
Indications
No indication recorded.