Status:
COMPLETED
Healthy Normal Single Ascending Dose and Crohn's Patient Multiple Ascending Dose
Lead Sponsor:
Zealand Pharma
Conditions:
Inflammatory Bowel Disease
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
Healthy Normal Single Ascending Dose and Crohn's patient Multiple Ascending Dose
Detailed Description
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 Dos...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT00868660
Start Date
January 1 2009
End Date
February 1 2010
Last Update
November 2 2010
Active Locations (1)
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1
CRI Worldwide
Willingboro, New Jersey, United States, 08046