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Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT00868660 (opens ClinicalTrials.gov in a new tab)Other idZP08-216Other idAA75468
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
66 participants (actual)
Sponsor
Zealand Pharma · Industry
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
Jan 2009
Primary completion
Feb 2010
Completion
Feb 2010
First posted
25 Mar 2009 (estimated)
Last update posted
2 Nov 2010 (estimated)
Conditions
Inflammatory Bowel Disease

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200920102011
  1. Ph 1

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

    NCT00868660

    Jan 2009 to Feb 2010

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • ZP1848Drug

Arms2

  • Experimental

    ZP1848

    Healthy Subjects or Crohn's Disease patients

  • Placebo comparator

    Placebo

    Healthy subjects or Crohn's Disease patients

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. safety and tolerability

    Time frame · January2009-January2010

Secondary outcomes(1)

  1. Pharmacokinetics

    Time frame · Jan 2009 - Jan 2010

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 60 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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