A single-center, open-label Phase 1 study to assess safety and medical endoscopic sampling methodology and to characterize the pharmacokinetics of oral doses of AG014 in Healthy Subjects

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Study title: 
A single-center, open-label Phase 1 study to assess safety and medical endoscopic sampling methodology and to characterize the pharmacokinetics of oral doses of AG014 in Healthy Subjects
Date receipt dossier: 
7 avr 2014
EudraCT number: 
2014-000190-39
Pharmaceutical study code: 
AG014-CSD-UC-001
Company / Sponsor: 
ActoGenix
Phase: 
I
Treated organism: 
Humans
Indication category: 
Gastrointestinal disorders
Disease: 
Inflammatory bowel disease
Therapeutic approach: 
Immunotherapy
Genetic modification: 
gene expressing certolizumab
Method of transfer of nucleic acid of interest: 
Lactococcus lactis strain MG1363
Administered biological material: 
Recombinant Lactococcus (sAGX0354)
Route of administration: 
Oral
Locations in Belgium: 
SGS Life Science Services, Cinical Pharmacology Unit, Antwerpn
Type of procedure: 
Contained use only
Current status: 
Authorized