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

EudraCT number

2014-000190-39

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

Pharmaceutical study code

AG014-CSD-UC-001

© Sciensano - Version 1.0 (20260902.1)