This study will evaluate the safety, tolerability, and mechanism of action of multiple doses of QAX576 in patients with pulmonary fibrosis secondary to systemic sclerosis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
8
- Safety assessments including vital Signs, ECG's, Echocardiograms and blood draws. - The pharmacokinetics and pharmacodynamics of multiple doses of the drug will be assessed by blood draws at the 3 dosing visits. A blood sample will also be collected.
Time frame: throughout the study
- The effect of the drug on biomarkers of pulmonary fibrosis and systemic sclerosis. - Pulmonary function tests. - Disease specific measurements, active hand extension, oral aperture, MRSS.
Time frame: throughout the study
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