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

Completed · Phase 1 · Has a placebo group

Conditions studied: Inflammatory Bowel Disease

In brief

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

Key facts

Study ID

NCT00868660

Run by

Zealand Pharma

People needed

66

Starts

2009-01-01

Expected to finish

2010-02-01

Last updated by the study team

2010-11-02

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• CRI Worldwide — Willingboro, New Jersey, United States

Full record on ClinicalTrials.gov

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