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Healthy Normal Single Ascending Dose and Crohn's Patient Multiple Ascending Dose

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ClinicalTrials.gov Identifier: NCT00868660
Recruitment Status : Completed
First Posted : March 25, 2009
Last Update Posted : November 2, 2010
Sponsor:
Information provided by:
Zealand Pharma

Study Description
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Brief Summary:
Healthy Normal Single Ascending Dose and Crohn's patient Multiple Ascending Dose

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Disease Drug: ZP1848 Phase 1

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

Study Design
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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

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U.S. FDA Resources

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. safety and tolerability [ Time Frame: January2009-January2010 ]

Secondary Outcome Measures :
  1. Pharmacokinetics [ Time Frame: Jan 2009 - Jan 2010 ]

Eligibility Criteria
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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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
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