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

This study has been completed.
Information provided by:
Zealand Pharma Identifier:
First received: March 23, 2009
Last updated: November 1, 2010
Last verified: November 2010
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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics [ Time Frame: Jan 2009 - Jan 2010 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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.
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Please refer to this study by its identifier: NCT00868660

United States, New Jersey
CRI Worldwide
Willingboro, New Jersey, United States, 08046
Sponsors and Collaborators
Zealand Pharma
Study Director: Christian Thorkildsen Zealand Pharma A/S
  More Information

Responsible Party: Christian Thorkildsen, Project Director, Zealand Pharma A/S 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
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases processed this record on April 27, 2016