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Healthy Normal Single Ascending Dose and Crohn's Patient Multiple Ascending Dose - NCT00868660-08046(Clinical Trial 458764)



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City:  Willingboro
State:  
NJ
Zip Code: 08046
Conditions: Inflammatory Bowel Disease
Purpose: Healthy Normal Single Ascending Dose and Crohn's patient Multiple Ascending Dose
Study summary: A Phase I, Double blind, Placebo-controlled, safety and tolerability study of ZP1848 administered as Ascending single Dose, SUBCUTANEOUS bolus injections in healthy SUBJECTS followed by a Multiple Dose cohort of patients with stable Crohn's disease in remission
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.
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Data Source: ClinicalTrials.gov
Date Processed: October 22, 2010
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