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Healthy Normal Single Ascending Dose and Crohn's Patient Multiple Ascending Dose
This study has been completed.
Sponsor:
Zealand Pharma
Information provided by:
Zealand Pharma
ClinicalTrials.gov Identifier:
NCT00868660
First received: March 23, 2009
Last updated: November 1, 2010
Last verified: November 2010
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Purpose
Healthy Normal Single Ascending Dose and Crohn's patient Multiple Ascending Dose
| Condition | Intervention | Phase |
|---|---|---|
| Inflammatory Bowel Disease | Drug: ZP1848 | Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase I, Double Blind, Placebo-Controlled Study of ZP1848 Administered as Subcutaneous Bolus Injections in Healthy Subjects Followed by Multiple Doses in Patients With Crohn's Disease in Remission |
Resource links provided by NLM:
Further study details as provided by Zealand Pharma:
Primary Outcome Measures:
- safety and tolerability [ Time Frame: January2009-January2010 ]
Secondary Outcome Measures:
- Pharmacokinetics [ Time Frame: Jan 2009 - Jan 2010 ]
| Enrollment: | 66 |
| Study Start Date: | January 2009 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: ZP1848
Healthy Subjects or Crohn's Disease patients
|
Drug: ZP1848
sc. bolus
|
|
Placebo Comparator: Placebo
Healthy subjects or Crohn's Disease patients
|
Drug: ZP1848
sc. bolus
|
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
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00868660
Please refer to this study by its ClinicalTrials.gov identifier: NCT00868660
Locations
| United States, New Jersey | |
| CRI Worldwide | |
| Willingboro, New Jersey, United States, 08046 | |
Sponsors and Collaborators
Zealand Pharma
Investigators
| Study Director: | Christian Thorkildsen | Zealand Pharma A/S |
More Information
| Responsible Party: | Christian Thorkildsen, Project Director, Zealand Pharma A/S |
| ClinicalTrials.gov Identifier: | NCT00868660 History of Changes |
| Obsolete Identifiers: | NCT01429922 |
| Other Study ID Numbers: |
ZP08-216 AA75468 |
| Study First Received: | March 23, 2009 |
| Last Updated: | November 1, 2010 |
Additional relevant MeSH terms:
|
Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on July 27, 2017