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

This study has been completed.
Sponsor:
Information provided by:
Zealand Pharma
ClinicalTrials.gov Identifier:
NCT00868660
First received: March 23, 2009
Last updated: November 1, 2010
Last verified: November 2010

March 23, 2009
November 1, 2010
January 2009
February 2010   (final data collection date for primary outcome measure)
safety and tolerability [ Time Frame: January2009-January2010 ] [ Designated as safety issue: Yes ]
To assess the safety and tolerabily of a single subcutaneous bolus injections of ZP1848 when administered in healthy adults and multiple subcutaneous bolus injections of ZP1848 when administered in adult patients with stale Chron's disease in remission [ Time Frame: January2009-August2009 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00868660 on ClinicalTrials.gov Archive Site
Pharmacokinetics [ Time Frame: Jan 2009 - Jan 2010 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Healthy Normal Single Ascending Dose and Crohn's Patient Multiple Ascending Dose
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
Healthy Normal Single Ascending Dose and Crohn's patient Multiple Ascending Dose
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
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Inflammatory Bowel Disease
Drug: ZP1848
sc. bolus
  • Experimental: ZP1848
    Healthy Subjects or Crohn's Disease patients
    Intervention: Drug: ZP1848
  • Placebo Comparator: Placebo
    Healthy subjects or Crohn's Disease patients
    Intervention: Drug: ZP1848
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
66
February 2010
February 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00868660
ZP08-216, AA75468
Yes
Not Provided
Not Provided
Christian Thorkildsen, Project Director, Zealand Pharma A/S
Zealand Pharma
Not Provided
Study Director: Christian Thorkildsen Zealand Pharma A/S
Zealand Pharma
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP