This is a Phase 1, randomised, single-blind, placebo-controlled, 2 stage study design with 2 multiple dose cohorts of healthy elderly subjects.~Randomisation will be in a 3:1 ratio to ensure that 6 subjects receive ASLAN003 and 2 subjects receive placebo in a fed condition. Up to a maximum of 16 subjects (two cohorts) are planned in this study.~Subjects will be randomised to receive ASLAN003 100mg or matched placebo once daily for 14 consecutive days.~After 8 subjects have completed 14 days of dosing, the Investigator, and the Sponsor will review the available safety and PK data from all subjects before deciding to proceed with stage 2 of the study. In Stage 2, a further 8 subjects will be randomised to receive ASLAN003 100mg or matched placebo once daily for 14 consecutive days.~Following a screening visit that must fall within 28 days prior to the first dose of Investigational Product (IP) for both parts, subjects who qualify (according to the protocol-defined inclusion and exclusion criteria) will be admitted to the study centre on Day -1. Dose administration for each study part will commence on Day 1.~The subjects will stay at the study centre throughout the 14 days of dosing (D-1 toD15). Full PK blood collection will be done on D1, D8 and D14, and single trough PK blood collection on D4 and D11. All subjects will be discharged on D15 and asked to return for single PK blood sampling on D16, D17, D18, and D19 (+5days post-dose), with full outpatient visit including safety follow up and lab test on Day 19.
This is a Phase 1, randomised, single-blind, placebo-controlled, 2 stage study design with 2 multiple dose cohorts of healthy elderly subjects.~The purpose of the study is to determine the safety, tolerability and pharmacokinetics of ASLAN003 in healthy elderly male and female subjects.