NCT00976378

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: TME Pharma AG · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Autologous Stem Cell Transplantation

Interventions

Type	Name	Description
DRUG	NOX-A12	single ascending IV doses, ranging from 0.05 mg/kg to 10.8 mg/kg
DRUG	NOX-A12	single IV dose, at efficacious dose level

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2009-09-14
• Last updated: 2014-06-26

Locations

1 site across 1 country: Germany