Inflammatory Bowel Disease
Conditions
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 Dose cohort of patients with stable Crohn's disease in remission
Interventions
DRUGZP1848
sc. bolus
Sponsors
Zealand Pharma
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety and tolerability | January2009-January2010 |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics | Jan 2009 - Jan 2010 |
Countries
United States
Outcome results
None listed