This study is designed to investigate whether GC1008, an antibody that neutralizes TGFb, is safe in treating patients with idiopathic pulmonary fibrosis. The highest dose without excessive side effects will be identified. Tests will determine how long GC1008 is in the body and how it is excreted.

Condition	Intervention	Phase
Idiopathic Pulmonary Fibrosis IPF	Drug: GC1008, Human Anti-Transforming Growth Factor-b 1,2,3 mAb	Phase I

Further Study Details: 

Primary Outcomes: To evaluate safety, tolerability, and PK of single IV infusions of GC1008 in patients with IPF
Secondary Outcomes: To evaluate potential clinical outcomes and bioactivity of GC1008

Ages Eligible for Study:  18 Years   -   79 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Willing and able to provide written informed consent prior to any study-related procedures;
• Patients should have an established diagnosis of IPF.
• Must be able to perform a simple, standardized exercise test.

Exclusion Criteria:

• Women who are pregnant or lactating ; are of childbearing potential unless taking medically acceptable contraceptive precautions; or who plan to become pregnant within 9 months after the infusion.
• History of clinically significant environmental exposure, including dust, molds, asbestos, pigeons or other birds that may result in interstitial lung disease, or ingestion of a drug known to cause pulmonary fibrosis such as bleomycin;
• History of clinically significant respiratory diseases other than IPF.;
• History of clinically significant cardiac, hepatic, or renal disease;
• History of cancer, precancerous state (e.g. familial polyposis), other than non-melanomatous skin cancer, within 5 years prior to Screening. 10. ;
• Use of any investigational drug administered as part of a clinical trial within 12 weeks before Screening;
• Other pathology that might interfere with the assessment of the safety or efficacy of the test article; or
• Other clinically significant, uncontrolled medical condition that, in the Investigator’s opinion, might interfere with the assessment or follow-up.

Please refer to this study by ClinicalTrials.gov identifier  NCT00125385

Colorado
      National Jewish Medical and Research Center, Denver,  Colorado,  80206,  United States; Recruiting

Study ID Numbers:  GC100800103
Last Updated:  August 1, 2005
Record first received:  July 29, 2005
ClinicalTrials.gov Identifier:  NCT00125385
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-02