Healthy Normal Single Ascending Dose and Crohn's Patient Multiple Ascending Dose - Full Text View

Purpose

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

Condition	Intervention	Phase
Inflammatory Bowel Disease	Drug: ZP1848	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

U.S. FDA Resources

Further study details as provided by Zealand Pharma:

Primary Outcome Measures:

safety and tolerability [ Time Frame: January2009-January2010 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetics [ Time Frame: Jan 2009 - Jan 2010 ] [ Designated as safety issue: No ]


Enrollment:	66
Study Start Date:	January 2009
Study Completion Date:	February 2010
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ZP1848 Healthy Subjects or Crohn's Disease patients	Drug: ZP1848 sc. bolus
Placebo Comparator: Placebo 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 60 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations


United States, New Jersey
CRI Worldwide
Willingboro, New Jersey, United States, 08046

Sponsors and Collaborators

Zealand Pharma

Investigators


Study Director:	Christian Thorkildsen	Zealand Pharma A/S

More Information


Responsible Party:	Christian Thorkildsen, Project Director, Zealand Pharma A/S
ClinicalTrials.gov Identifier:	NCT00868660 History of Changes
Obsolete Identifiers:	NCT01429922
Other Study ID Numbers:	ZP08-216 AA75468
Study First Received:	March 23, 2009
Last Updated:	November 1, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:


Intestinal Diseases Inflammatory Bowel Diseases Gastrointestinal Diseases Digestive System Diseases Gastroenteritis

ClinicalTrials.gov processed this record on September 26, 2016