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.
For general information, see Learn About Clinical Studies.
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 May 25, 2017