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

Inflammatory Bowel Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00868660
• Other study ID #: ZP08-216
• Secondary ID: AA75468
• Status: Completed
• Phase: Phase 1
• First received: March 23, 2009
• Last updated: November 1, 2010
• Start date: January 2009
• Est. completion date: February 2010

Study information

• Verified date: November 2010
• Source: Zealand Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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

Other known NCT identifiers

• NCT01429922

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases

Intervention

Drug:
• ZP1848
sc. bolus

Locations

Country	Name	City	State
United States	CRI Worldwide	Willingboro	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Zealand Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety and tolerability		January2009-January2010	Yes
Secondary	Pharmacokinetics		Jan 2009 - Jan 2010	No