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

Zealand Pharma

Status and phase

Completed

Phase 1

Conditions

Inflammatory Bowel Disease

Treatments

Drug: ZP1848

Study type

Interventional

Funder types

Industry

Identifiers

NCT00868660

ZP08-216

AA75468

Details and patient eligibility

About

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

Full 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

Enrollment

66 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.