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

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Disease
• Intervention / Treatment: Drug: ZP1848

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 Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Willingboro, New Jersey, United States, 08046
      • CRI Worldwide

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
safety and tolerability	January2009-January2010

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics	Jan 2009 - Jan 2010

Collaborators and Investigators

• Sponsor: Zealand Pharma
• Investigators: Study Director: Christian Thorkildsen, Zealand Pharma A/S

Study record dates

Study Major Dates

• Study Start: January 1, 2009
• Primary Completion (ACTUAL): February 1, 2010
• Study Completion (ACTUAL): February 1, 2010

Study Registration Dates

• First Submitted: March 23, 2009
• First Submitted That Met QC Criteria: March 24, 2009
• First Posted (ESTIMATE): March 25, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): November 2, 2010
• Last Update Submitted That Met QC Criteria: November 1, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases
• Other Study ID Numbers: ZP08-216; AA75468