drugset / Trial / NCT00998283
Assess the Safety, Tolerability, and Pharmacokinetic (PK) Characteristics of HM10460A (HNK460) in Healthy Adult Korean Subjects
RandomizedParallel-groupDouble-blindTreatment
Summary
* Study Design * Randomized, Double-blind, Placebo-controlled, escalating single-dose design. * Five ascending dose cohorts. * In each cohort, subjects will be randomized to receive a single dose of HM10460A or placebo (negative control) * Objectives * The primary objective of the study is to assess the safety and tolerability of single escalating subcutaneous doses of HM10460A in healthy adult Korean Subjects
Timeline
- Start
- 2009-10
- Primary completion
- 2010-09
- Completion
- 2010-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Eflapegrastim | Protein / enzyme biologic | 5 ug/kg | Subcutaneous |
| Subject | Eflapegrastim | Protein / enzyme biologic | 15 ug/kg | Subcutaneous |
| Subject | Eflapegrastim | Protein / enzyme biologic | 45 ug/kg | Subcutaneous |
| Subject | Eflapegrastim | Protein / enzyme biologic | 135 ug/kg | Subcutaneous |
| Subject | Eflapegrastim | Protein / enzyme biologic | 350 ug/kg | Subcutaneous |
Indications
No indication recorded.