DRUG
ZP1848
sc. bolus
Status
Completed
Phase
Phase 1
Enrollment
66
Locations
1
Results
Not posted
Publications
0
Study summary
Healthy Normal Single Ascending Dose and Crohn's patient Multiple Ascending Dose
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
Interventions
DRUG
sc. bolus
Timeline
First posted
Mar 25, 2009
Study start
Jan 2009
Primary completion
Feb 2010
Study completion
Feb 2010
Results posted
Not reported
Registry updated
Nov 2, 2010
Outcomes
safety and tolerability
Time frame · January2009-January2010
Pharmacokinetics
Time frame · Jan 2009 - Jan 2010
Eligibility
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.
Study locations
United States. Showing up to 24 locations stored in the fast local snapshot.
CRI Worldwide
Willingboro, New Jersey, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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