drugset / Trial / NCT03029000

Study of the Effect of a 5-Day Regimen of Study Drug on Peripheral Stem Cell Mobilization in Healthy Participants

NCT03029000

Phase 3 Terminated 1 enrolled Teva Branded Pharmaceutical Products R&D, Inc.
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

EvaluationDrugModalityDoseRoute
Subject filgrastim Protein / enzyme biologic 10 ug/kg Subcutaneous

Indications

No indication recorded.