drugset / Trial / NCT02306915
PK, PD, Safety and Tolerability of Lipegfilgrastim in Healthy Japanese and Caucasian Participants
RandomizedParallel-groupTriple-blindOther
Summary
Cohorts of Japanese participants will be enrolled and treated prior to cohorts of Caucasian participants for the sake of matching. Every effort will be made to match Caucasian and Japanese participants on a cohort basis at enrollment. Reasonable effort will be made to maintain balance between male and female participants within the cohorts. There will be no replacement of participants following randomization.
Timeline
- Start
- 2014-10
- Primary completion
- 2015-03
- Completion
- 2015-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | lipegfilgrastim | Protein / enzyme biologic | 30 ug/kg | Subcutaneous |
| Subject | lipegfilgrastim | Protein / enzyme biologic | 60 ug/kg | Subcutaneous |
| Subject | lipegfilgrastim | Protein / enzyme biologic | 100 ug/kg | Subcutaneous |
Indications
No indication recorded.