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