Healthy Normal Single Ascending Dose and Crohn's Patient Multiple Ascending Dose
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00868660 |
Recruitment Status
:
Completed
First Posted
: March 25, 2009
Last Update Posted
: November 2, 2010
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Inflammatory Bowel Disease | Drug: ZP1848 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 66 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Quadruple (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 |
Study Start Date : | January 2009 |
Actual Primary Completion Date : | February 2010 |
Actual Study Completion Date : | February 2010 |

Arm | Intervention/treatment |
---|---|
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
|
- safety and tolerability [ Time Frame: January2009-January2010 ]
- Pharmacokinetics [ Time Frame: Jan 2009 - Jan 2010 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00868660
United States, New Jersey | |
CRI Worldwide | |
Willingboro, New Jersey, United States, 08046 |
Study Director: | Christian Thorkildsen | Zealand Pharma A/S |
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 |
First Posted: | March 25, 2009 Key Record Dates |
Last Update Posted: | November 2, 2010 |
Last Verified: | November 2010 |
Additional relevant MeSH terms:
Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |