Single Ascending Dose and Multiple Ascending Dose Phase I study of PXS-4728A Administered Orally in Healthy Adult Males.

INTERVENTION: The interventional product, PXS‐4728A, is a powder which will be dissolved in water for irrigation (stock solution). The final product will be formulated at 1‐20 mg/100 mL in flavoured water at room temperature for oral administration. The study is divided into 2 parts: Part A ‐ Single Ascending Dose (SAD) study in which PXS‐4728A will be administered as a single dose (1/ 3/ 6/ 10/ 15 or 20 mg). Part B ‐ Multiple Ascending Dose (MAD) study in which PXS‐4728A will be administered once daily from Day 1 up to Day 14. However the dose for this part of the study will be decided based on the results of the SAD study. The interventional product will be administered to the healthy volunteers while they are confined in the clinical facility under the direct supervision of the study team. This will ensure that strict adherence to the intervention are followed. CONDITION: Chronic Obstructive Pulmonary Disease Cystic Fibrosis PRIMARY OUTCOME: 1. To evaluate the safety and tolerability of single ascending or repeated oral doses of PXS‐4728A: ; a) Recording of adverse events throughout the study. ; b) Change from baseline in: ; ‐ Electrocardiogram (ECG) readings ; ‐ Clinical monitoring of blood pressure (BP) ; ‐ Heart rate (HR) ; ‐ Laboratory assessments SECONDARY OUTCOME: 1. To evaluate plasma pharmacokinetic parameters after single and repeat oral dosing of PXS‐4728A: ; a) AUC (0‐t) and AUC (0‐inf) ; b) Cmax – maximum concentration ; c) Tmax – time to maximum observed plasma drug concentration ; d) t1/2 – Terminal half‐life ; e) Accumulation ratio (For Part B only) 2. Assessment of plasma pharmacodynamic parameters after single and repeat dosing of PXS‐4728A: ; a) SSAO activity in plasma using enzymatic assay ; b) SSAO concentration in plasma using ELISA method INCLUSION CRITERIA: ‐ healthy males. ‐ BMI ‐ 18.5 to 30 kg/m2. ‐ no clinically relevant abnormality in an ECG; QTcF (QTc Fredericia’s correction) less than or equal to 450 ms, PR interval of 120‐210 ms and a QRS duration less than or equal to 120 ms. ‐ adequate venous access. ‐ agree to use two approved methods of contraception from screening and until 30 days after administration of the study drug. ‐ has given written informed consent.