Lead Sponsor

Neovacs

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

No

•1. Male or female aged 18 to 65 years, inclusive.
•2. Have had a diagnosis of Crohn's disease for at least 6 months.
•3. Moderate to severe active Crohn's disease defined as a Crohn's Disease Activity Index (CDAI) score ≥ 220 and ≤ 450, and presence of colonic mucosal ulcerations in at least 2 segments, or ulcerations on ≥ 10% of the mucosal surface if only one segment is involved.
•4. Have developed secondary resistance to anti-TNFα therapy.

•1. Primary non-response to a previously received treatment directed against TNFα Or Intolerance related to the primary pharmacological effect of anti-TNFα such as for instance, but not limited to, severe or opportunistic infections and demyelinating or autoimmune diseases.
•2. History of severe systemic bacterial, fungal, viral, or parasitic infections within the 3 months prior to screening; or the occurrence of any acute infection within 2 weeks of the first administration of study drug.
•3. Treatment with immunosuppressive or immunomodulatory drugs