A single-center, open-label Phase 1 study to assess the effect of food/beverage and to characterisze the pharmacokinetics of single and multiple oral doses of AG013 in Healthy Subjects

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Study title: 
A single-center, open-label Phase 1 study to assess the effect of food/beverage and to characterisze the pharmacokinetics of single and multiple oral doses of AG013 in Healthy Subjects
Date receipt dossier: 
8 mai 2012
EudraCT number: 
2012-000621-50
Pharmaceutical study code: 
AG013-CSD-MU-004
Company / Sponsor: 
ActoGenix
Phase: 
I
Treated organism: 
Humans
Indication category: 
Cancer therapy
Disease: 
Radiotherapy-induced oral mucositis
Therapeutic approach: 
Prevention
Genetic modification: 
Human Trefoil Factor 1
Method of transfer of nucleic acid of interest: 
Lactococcus lactis strainMG1363
Administered biological material: 
Recombinant Lactococcus (sAGX0085)
Route of administration: 
Oral mouth rinse
Locations in Belgium: 
UZ Gent
Type of procedure: 
Contained use only
Current status: 
Authorized