Safety and Tolerability Study of AVID200 in Pts With Diffuse Cutaneous Systemic Sclerosis

The trial is designed to evaluate the safety and tolerability of sequential escalating doses of AVID200 (study drug), in order delineate a potential effective range of tolerated doses to be further evaluated in Phase 2. Patients will be treated and followed on an outpatient basis throughout the trial, unless hospitalization is required for other reasons, or to assure patient safety. The choice of doses for further Phase 2 study will be based on clinical and laboratory data obtained during this trial, including safety, PK, and preliminary anti-fibrotic activity. Upon completion of Cycle 1, and provided re-treatment criteria are met, patients may receive up to 2 additional cycles of study drug unless a criterion for treatment discontinuation has been met.