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