Back to results

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

Primary Purpose

Inflammatory Bowel Disease

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

ZP1848

About this trial

This is an interventional treatment trial for Inflammatory Bowel Disease

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

CRI Worldwide

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ZP1848

Placebo

Arm Description

Healthy Subjects or Crohn's Disease patients

Healthy subjects or Crohn's Disease patients

Outcomes

Primary Outcome Measures

safety and tolerability

Secondary Outcome Measures

Pharmacokinetics

Full Information

NCT ID

NCT00868660

First Posted

March 23, 2009

Last Updated

November 1, 2010

Sponsor

Zealand Pharma

1. Study Identification

Unique Protocol Identification Number

NCT00868660

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2010

Overall Recruitment Status

Completed

Study Start Date

January 2009 (undefined)

Primary Completion Date

February 2010 (Actual)

Study Completion Date

February 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Zealand Pharma

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inflammatory Bowel Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ZP1848

Arm Type

Experimental

Arm Description

Healthy Subjects or Crohn's Disease patients

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Healthy subjects or Crohn's Disease patients

Intervention Type

Drug

Intervention Name(s)

ZP1848

Intervention Description

sc. bolus

Primary Outcome Measure Information:

Title

safety and tolerability

Time Frame

January2009-January2010

Secondary Outcome Measure Information:

Title

Pharmacokinetics

Time Frame

Jan 2009 - Jan 2010

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christian Thorkildsen

Organizational Affiliation

Zealand Pharma A/S

Official's Role

Study Director

Facility Information:

Facility Name

CRI Worldwide

City

Willingboro

State/Province

New Jersey

ZIP/Postal Code

08046

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs