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

NCT ID: NCT00868660

Last Updated: 2010-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-02-28

Brief Summary

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

Detailed Description

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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

Conditions

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Inflammatory Bowel Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ZP1848

Healthy Subjects or Crohn's Disease patients

Group Type EXPERIMENTAL

ZP1848

Intervention Type DRUG

sc. bolus

Placebo

Healthy subjects or Crohn's Disease patients

Group Type PLACEBO_COMPARATOR

ZP1848

Intervention Type DRUG

sc. bolus

Interventions

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ZP1848

sc. bolus

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zealand Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Zealand Pharma A/S

Principal Investigators

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Christian Thorkildsen

Role: STUDY_DIRECTOR

Zealand Pharma A/S

Locations

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CRI Worldwide

Willingboro, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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AA75468

Identifier Type: -

Identifier Source: secondary_id

ZP08-216

Identifier Type: -

Identifier Source: org_study_id

NCT01429922

Identifier Type: -

Identifier Source: nct_alias