TFFP - TFF Pharma reports preliminary data from Phase 1 trial of tacrolimus inhalation powder

TFF Pharmaceuticals (TFFP) has completed enrollment for the Phase 1 clinical trial for Tacrolimus Inhalation Powder (inhaled tacrolimus). In the Single Ascending Dose phase, single doses of inhaled tacrolimus of 0.5 mg, 1.0 mg, 2.5 mg to 5.0 mg were administered to healthy subjects. Peak and trough blood levels were measured 15 min and 12 hours after dosing for each subject, respectively. In the subjects that received inhaled tacrolimus in the low dose group, the mean trough blood levels reached 1.1 ng/mL, while blood levels in the highest dose group reached 10.0 ng/mL.In addition, at 2.5 mg while fasting or 30 minutes after a high fat meal, there were no significant differences in systemic exposure. Furthermore, during the Multiple Ascending Dose phase, repeated dosing of inhaled tacrolimus every 12 hours over 7 days demonstrated that subjects receiving 0.5 mg twice daily and 1.0 mg twice daily dose achieved 12-hour trough

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TFF Pharma reports preliminary data from Phase 1 trial of tacrolimus inhalation powder