www.fdanews.com/articles/74460-phase-i-study-for-sle-project-57-57-concluded
PHASE I STUDY FOR SLE PROJECT 57-57 CONCLUDED
July 19, 2005
The first clinical study with Active Biotech's candidate drug 57-57 against SLE (Systemic Lupus Erythematosus) has been successfully concluded. The Phase I study, which comprised a total of 30 healthy volunteers, was performed in cooperation with the Phase I unit at the Karolinska University Hospital in Stockholm.
The results show that 57-57 is very well-tolerated in all of the studied dose levels, both as single and repeated dose, and that it is well suitable to be given as an oral, daily treatment. Preparations for a patient study (Phase I) with 57-57 are ongoing. This study is planned to start before the year's end.