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

EudraCT number

2012-000621-50

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

Pharmaceutical study code

AG013-CSD-MU-004

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