Healthy Normal Single Ascending Dose and Crohn's Patient Multiple Ascending Dose

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

Healthy Normal Single Ascending Dose and Crohn's patient Multiple Ascending Dose

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zealand Pharma

Criteria

Inclusion Criteria:

• Healthy adult male and/or females, 18 to 50 years of age

• Body mass index (BMI)18-30. Chrons Inclusion

• Adult male and/or females, 18 to 60 years of age (inclusive).

• Body mass index (BMI) ≥ 18 and ≤ 30 (kg/m2).

• Crohn's Disease Activity Index (CDAI) score < 150.

• In a stable state of Crohn's disease as per the Investigator's opinion.

• Free of steroid treatment (therapy targeted for the GI tract only) within the 3 months prior to Day 1.

Exclusion Criteria:

• History or presence of dysplasia, cancer, chronic hepatitis, HIV, tuberculosis (TB), or histoplasmosis.

• Fistula within the 3 months prior to dosing. 3. Ostomy (having ostomy now or at any time in the past). 4. Any surgery for the treatment of inflammatory bowel disease (IBD) within the 3 months prior to Day 1. 5. Short Bowel Syndrome (SBS). 6. Any other condition, chronic disease, or prior therapy, which in the opinion of the Investigator/Investigator's designee would put the patient at undue risk or would make the patient unsuitable for the study.