Study to Evaluate the Pharmacodynamics and Safety of HGS1025 in Patients With Ulcerative Colitis

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the pharmacodynamics, safety, and pharmacokinetics of HGS1025 in patients with moderate to severe ulcerative colitis.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Human Genome Sciences Inc.

Criteria

Inclusion Criteria:

• Adults at least 18 years of age

• Active, moderate to severe ulcerative colitis (UC) confirmed by endoscopy

• Currently on 1 or more of the following UC treatment medications: 5-aminosalicylates (5-ASA), corticosteroids, azathioprine, 6-mercaptopurine (6MP), and/or other immunosuppressive or immunomodulatory agents including cyclosporine, tacrolimus, methotrexate, and mycophenolic acid

• Not pregnant or nursing

• Females of non-childbearing potential or females of childbearing potential must be willing to practice abstinence from intercourse from 2 weeks prior to first dose of study agent and for 8 weeks after the last dose of study agent or use effective contraception for 1 month prior to the 1st dose of study agent and through 8 weeks after the last dose of study agent

• Males must agree to use effective contraception throughout the study and for 8 weeks after the last dose of study agent

• Have the ability to provide informed consent and comply with study procedures

Exclusion Criteria:

• Received any of the following within 60 days of the first dose of study agent:

Anti-TNFα therapy; integrin receptor antagonist; intravenous immunoglobulin; high dose prednisone or prednisone equivalent (greater than 60 mg/day); any investigational agent including immunosuppressive/immunomodulatory or non-biologic agents

• Have had a change in corticosteroid, 5-ASA, or other immunosuppressive/immunomodulatory agents within 30 days of Day 0

• History of liver disease

• History of a major organ transplant

• History of prior large bowel resection

• Current unstable or uncontrolled acute or chronic diseases not due to UC

• History of malignant neoplasm within the last 5 years, except for some types of adequately treated cancers of the skin or carcinoma in situ of the uterine cervix

• Current or recent drug or alcohol abuse or dependence

• History of a positive test for HIV or test positive for Hepatitis B (HBsAg) or Hepatitis C

• Have a history of severe drug allergies