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

This study is currently recruiting participants.

Verified by Zealand Pharma, April 2009

First Received: March 23, 2009 Last Updated: April 28, 2009 History of Changes

Sponsored by:	Zealand Pharma
Information provided by:	Zealand Pharma
ClinicalTrials.gov Identifier:	NCT00868660

Purpose

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

Condition	Intervention	Phase
Inflammatory Bowel Disease	Drug: ZP1848	Phase I

Genetics Home Reference related topics: Crohn disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Single Group Assignment, Safety Study
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

Further study details as provided by Zealand Pharma:

Primary Outcome Measures:

safety and tolerability [ Time Frame: January2009-August2009 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetics [ Time Frame: Jan 2009 - Aug 2009 ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	January 2009
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
ZP1848: Experimental Healthy Subjects or Crohn's Disease patients	Drug: ZP1848 sc. bolus
Placebo: Placebo Comparator Healthy subjects or Crohn's Disease patients	Drug: ZP1848 sc. bolus

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

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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 50 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00868660

Contacts

Contact: Brandi N Carmona

732-502-8900 ext 6967

Brandi.Carmona@mdsinc.com

Locations

United States, New Jersey
MDS Pharma Services	Recruiting
Neptune, New Jersey, United States, 07753
Contact: Brandi N Carmona 732-502-8900 ext 6967 Brandi.Carmona@mdsinc.com
Principal Investigator: Sandra M Connolly

Sponsors and Collaborators

Zealand Pharma

Investigators

Study Director:

Christian Thorkildsen

Zealand Pharma A/S

More Information

No publications provided

Responsible Party:	Zealand Pharma A/S ( Christian Thorkildsen )
Study ID Numbers:	ZP08-216, AA75468
Study First Received:	March 23, 2009
Last Updated:	April 28, 2009
ClinicalTrials.gov Identifier:	NCT00868660 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Crohn's Disease
Digestive System Diseases
Gastrointestinal Diseases
Ileitis
Enteritis

Crohn Disease
Inflammatory Bowel Diseases
Healthy
Gastroenteritis
Intestinal Diseases

Additional relevant MeSH terms:

Digestive System Diseases
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Intestinal Diseases

ClinicalTrials.gov processed this record on May 07, 2009