drugset / Trial / NCT03029000
Study of the Effect of a 5-Day Regimen of Study Drug on Peripheral Stem Cell Mobilization in Healthy Participants
NaSingle-groupOpen-labelTreatment
Summary
A multi-center, open-label, single-arm clinical study to assess effects of a 5-day regimen of 10 micrograms per kilogram (mcg/kg) of tbo-filgrastim administered subcutaneously daily on the mobilization of cluster of differentiation 34+ (CD34+) cells in at least 60 healthy male and female participants. The pharmacokinetics, pharmacodynamics, safety, tolerability, and immunogenicity of tbo-filgrastim will be assessed.
Timeline
- Start
- 2017-08-02
- Primary completion
- 2017-10-30
- Completion
- 2017-10-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | filgrastim | Protein / enzyme biologic | 10 ug/kg | Subcutaneous |
Indications
No indication recorded.