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The preclinical and clinical data with LAT8881 available to date do not suggest any significant safety concerns. There are no established SAEs associated with administration of LAT8881, and no pattern of severe, related AEs.
A comprehensive series of preclinical safety studies were undertaken with LAT8881 to Good Laboratory Practice (GLP) standards and did not indicate toxicity concerns with chronic administration, nor that the product has genotoxic potential. Based on this analysis, it was deemed appropriate to commence a clinical study program.
Subsequently, a series of six clinical studies with intravenous and oral administration of LAT8881 has been completed in healthy males and healthy obese subjects. Across these studies, in total, 702 subjects received at least one dose of LAT8881 and 232 received at least one placebo dose. There were no significant safety concerns in any of these studies.
More recently, two clinical studies for oral administration of LAT8881 in neuropathic pain and migraine, have closed to recruitment. More than 70 subjects received at least one dose of LAT8881 in these studies, and the resulting safety data from these studies will be available by Q3 2020.