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Completed

NCT Number: NCT00868660

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

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

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Key information

Conditions

Inflammatory Bowel Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CRI Worldwide

Willingboro, New Jersey, 08046, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ZP1848

Drug

sc. bolus

Primary outcomes

  1. safety and tolerability

    Time frame: January2009-January2010

Secondary outcomes

  1. Pharmacokinetics

    Time frame: Jan 2009 - Jan 2010

Sponsors and collaborators

Lead sponsor

Zealand Pharma

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 25, 2009
Registry last updated
Nov 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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