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NOX-A12 First-in-human (FIH) Study

Autologous Stem Cell Transplantation Clinical Trial

Official title:
NOX-A12 to Mobilize Stem Cells in Healthy Volunteers - A Single-center, Single Dose, Open Label, Dose Escalation Study of Intravenous NOX-A12 in up to 48 Healthy Subjects

Clinical Trial Summary

This is the first time NOX-A12 will be administered to man. The principal aim of this study is to obtain safety and tolerability data when NOX-A12 is administered by single intravenous (IV) doses to healthy male and female subjects. This information, together with the pharmacokinetic and pharmacodynamic data, will help establish the doses and dosage regimen of administration suitable for subsequent studies in the patient population.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

  • Autologous Stem Cell Transplantation
Clinical Trial Details
NCT number NCT00976378
Study type Interventional
Source NOXXON Pharma AG
Contact
Status Completed
Phase Phase 1
Start date October 2009
Completion date May 2010
View Details
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