NCT01194934

NOX-A12 Multiple Ascending Dose Study in Healthy Volunteers

A Single Center, Open-label, Repeated Dose, Phase I Study in Healthy Subjects to Assess the Safety, Tolerability, Pharmacokinetics and the Effect on Mobilization of Hematopoietic Stem Cells of NOX-A12 Alone and in Combination With Filgrastim

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: TME Pharma AG · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is the second clinical study of NOX-A12. This study intends to provide information on the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of repeated intravenous doses of NOX-A12 (2.0 and 4.0 mg/kg/d) alone and to compare the mobilization of hematopoietic stem cells (HSC) obtained with NOX-A12 alone with that obtained in combination with filgrastim in healthy subjects. A single center, open-label, repeated dose study design is selected to best address the study objectives.The results from this study will establish the basis for further development of NOX-A12 in lymphoma patients undergoing autologous hematopoietic stem cell transplantation

Conditions

• Hematopoietic Stem Cell Transplantation

Interventions

Type	Name	Description
DRUG	NOX-A12	4 mg/kg daily IV for 5 days
DRUG	NOX-A12	2 mg/kg daily IV for 5 days
DRUG	Filgrastim	5 µg/kg SC daily for 5 days
DRUG	NOX-A12 in combination with Filgrastim	Safe and efficacious dose regimen according to results of groups A and B

Timeline

• Start date: 2010-08-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2010-09-03
• Last updated: 2014-06-26

Locations

1 site across 1 country: Germany