TFFP - TFF Pharma concludes tacrolimus single ascending dosing in three cohorts of early-stage study

TFF Pharmaceuticals ([[TFFP]] +3.1%) has completed the single ascending dosing of three cohorts of healthy subjects for its second clinical program, tacrolimus inhalation powder for the prevention of lung transplant rejection.This 64-subject Phase 1 study will assess the safety, tolerability and pharmacokinetics of tacrolimus, an immunosuppressive agent for the prophylactic treatment of lung transplant rejection. Subjects were dosed at a single site in Australia.To date, single ascending dose cohorts have shown to be safe with no clinically significant drug-associated adverse events, as well as achieved substantial immunosuppressive blood levels.In June, Tacrolimus Inhalation Powder received FDA Orphan Drug designation for prophylaxis of lung allograft rejection.Last month, the company announced positive topline safety data from its Phase 1 trial of voriconazole inhalation powder, in 64 healthy volunteers.

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TFF Pharma concludes tacrolimus single ascending dosing in three cohorts of early-stage study