A Phase 1, 2-Part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of ASLAN003 in Healthy Elderly Subjects

Exclusion Criteria

• •1. have participated in a study involving another investigational device or drug study within 90 days prior to randomisation in this study;
• •2. history of drug hypersensitivity reactions or hypersensitivity to drugs chemically related to the IP;
• •3. history or evidence of a clinically significant disorder, condition or disease (including, but not limited to, cardiopulmonary, oncologic, autoimmune, immunogenic, renal, metabolic, haematological or psychiatric), that, in the opinion of the Investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion;
• •4. existence of any surgical or medical condition which, in the judgement of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the IP;
• •5. clinically significant history or evidence of any active or suspected bacterial, viral, fungal or parasitic infection within the 30 days prior to randomisation (e.g. common cold, viral syndrome, flu-like symptoms, etc.);
• •6. active or recent history (within 30 days prior to randomisation) of acute viral infection of the skin (e.g. Herpes simplex, Molluscum contagiosum);
• •7. active or history of psoriasis, or a first-degree relative with active or history of psoriasis;
• •8. known history or evidence of active or latent tuberculosis infection (e.g. positive tuberculin skin test showing induration \>5 mm or positive tuberculin blood test) in absence of previous Bacillus Calmette Guerin vaccination, or recent exposure (within 6 months prior to randomisation in this study) to an individual with active tuberculosis or with intention to travel to a country with a high risk of tuberculosis during the study period (including the follow up period);
• •9. history of autoimmune disease including but not limited to lupus, rheumatoid arthritis, autoimmune thyroid disease and immune thrombocytopenia;
• •10. QTcF values higher than 450 ms at screening, unless assessed to be non-clinically significant by the Investigator or cardiologist;
• •11. history of regular alcohol consumption (within 6 months prior to randomisation in this study), defined as: an average weekly intake of greater than 21 units or any average daily intake of greater than 3 units. One unit is equivalent to a half pint (220 mL) of beer or 1 (25 mL) measure of spirits or 1 glass (125 mL) of wine;
• •12. history of drug abuse within 1 year prior to the first day of dose administration, as judged by the Investigator and/or has a positive urine drug screen for substances of abuse including marijuana, cocaine, amphetamines, opiates, phencyclidine, barbiturates, benzodiazepines, propoxyphene, methadone metabolites, and cannabinoids and tricyclin anti-depressants at screening or on admission to the study centre;
• •13. has donated plasma or blood or loss of more than 250 mL blood within 1 month prior to the first day of dose administration;
• •14. is considering or has scheduled any surgical procedure during study participation;
• •15. has received any type of vaccination within 30 days prior to randomisation in this study, or is planning to receive acellular, live or attenuated vaccines during the study;
• •16. current use or history of use of any systemic immunomodulatory /immunosuppressive therapy, including but not restricted to systemic steroids within 3 months prior to randomisation in this study;
• •17. requires treatment with any medication, either prescription or non-prescription, or herbal medications, within 14 days prior to the first dose of IP (exceptions are paracetamol or vitamin products at recommended daily doses);
• •18. administration of any prescribed or over-the-counter drug within 2 weeks prior to screening, with the exception of paracetamol, which can be used during the study;
• •19. current renal insufficiency ( defined as an estimated creatinine clearance of \<60 mL/min as determined from the reference range of CGH laboratory report.)
• •20. male subjects who plan to donate sperm in the 6 months following the receipt of IP;
• •21. is judged by the Investigator or the Sponsor to be inappropriate for the study.