NCT01841476

Safety and Efficacy of POL6326 for Mobilization of Hematopoietic Stem Cells in Healthy Volunteers

POL6326 - A Phase I, Open, Single Intravenous Infusion Dose, Pharmacokinetic and Pharmacodynamic Study in Healthy Volunteers Who Are Volunteering as Haematopoietic Stem Cell (HSC) Donors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Polyphor Ltd. · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Phase I study to determine and compare the safety/tolerability of single ascending doses of POL6326 by intravenous infusion.

Detailed description

Phase I Study * to determine and compare the safety of single ascending doses of POL6326 by intravenous infusion * to determine the relationship between 2-hour single intravenous infusion doses of POL6326 and the concentration of HSC and mature WBC in peripheral blood using immunophenotypic assays.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	POL6326

Timeline

• Start date: 2012-02-01
• Primary completion: 2015-08-01
• Completion: 2015-09-01
• First posted: 2013-04-26
• Last updated: 2015-11-25

Locations

1 site across 1 country: Germany