NCT00868660

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

November 2, 2010

Status Verified

November 1, 2010

Enrollment Period

1.1 years

First QC Date

March 23, 2009

Last Update Submit

November 1, 2010

Conditions

Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

  • safety and tolerability

    January2009-January2010

Secondary Outcomes (1)

  • Pharmacokinetics

    Jan 2009 - Jan 2010

Study Arms (2)

ZP1848

EXPERIMENTAL

Healthy Subjects or Crohn's Disease patients

Drug: ZP1848

Placebo

PLACEBO COMPARATOR

Healthy subjects or Crohn's Disease patients

Drug: ZP1848

Interventions

ZP1848DRUG

sc. bolus

PlaceboZP1848

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adult male and/or females, 18 to 50 years of age
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CRI Worldwide

Willingboro, New Jersey, 08046, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Christian Thorkildsen

    Zealand Pharma A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 23, 2009

First Posted

March 25, 2009

Study Start

January 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

November 2, 2010

Record last verified: 2010-11

Locations

US(1)