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

Phase 1

Completed

• Conditions: Inflammatory Bowel Disease
• Interventions: Drug: ZP1848

• Registration Number: NCT00868660
• Lead Sponsor: Zealand Pharma

Brief Summary

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

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 Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-03-23
• Study First Submitted QC: 2009-03-24
• Study First Posted: 2009-03-25
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-01
• Last Update Posted: 2010-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ZP1848	ZP1848	Healthy Subjects or Crohn's Disease patients
Placebo	ZP1848	Healthy subjects or Crohn's Disease patients

Primary Outcome Measures

Name	Time	Method
safety and tolerability	January2009-January2010

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics	Jan 2009 - Jan 2010

Trial Locations

Locations (1)

CRI Worldwide; 🇺🇸 Willingboro, New Jersey, United States