Earlier studies conducted under the collaboration included both clinical and preclinical studies. In a Phase I clinical trial investigating the safety and tolerability of oral AGI-1096 in combination with Astellas' tacrolimus (Prograf(R)) conducted in healthy volunteers, results indicated that regimens of AGI-1096 administered alone, and concomitant with tacrolimus, were generally well-tolerated and there were no serious adverse Events associated with either regimen during the course of the study. AGI-1096 has also demonstrated pharmacological activity in certain preclinical studies that were conducted as part of the ongoing collaboration.
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