NCT03029000

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

A Single-Arm Study of the Effect of a 5-day Regimen of Tbo-Filgrastim 10 mcg/kg of Body Weight Administered Subcutaneously on Peripheral Stem Cell Mobilization in Healthy Donors

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Tbo-filgrastim	solution for subcutaneous injection

Timeline

• Start date: 2017-08-02
• Primary completion: 2017-10-30
• Completion: 2017-10-30
• First posted: 2017-01-23
• Last updated: 2022-12-13
• Results posted: 2018-12-14

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated drug study