A Phase I Randomised, Double-Blind, Placebo-Controlled Dose Escalating Study of the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of Oral NP202 in Adult Healthy Volunteers

Exclusion Criteria13

• Subjects who:
• Have received blood products within 1 month prior to Screening.
• Have received any investigational research agent within 30 days or 5 half-lives (whichever is longer) prior to the first dose of Investigational Product.
• Have received an investigational vaccine within 6 months, a live attenuated vaccine within 60 days or a registered vaccine within 30 days prior to the first dose of the Investigational Product.
• Have a history of severe or life-threatening drug allergy and/or known drug hypersensitivity.
• Have a bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with blood draws.
• Have a current malignancy or previous malignancy that is likely to recur during the period of the study (with the exception of a past history of basal or squamous cell carcinomas).
• Have a psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder; disorder requiring lithium; or within five years prior to Screening, a history of suicide plan
• Have any clinically significant abnormality at Screening determined by medical history, physical examination, blood chemistry, haematology, urinalysis and a 12-lead electrocardiogram (ECG)
• Have positive Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C Screening test results
• Have a history of or current clinically significant gastrointestinal, hepatic, renal, cardiovascular, respiratory, endocrine, oncological, immunodeficiency, neurological, metabolic, haematological or autoimmune disorder
• Have clinical signs of active infection and/or a temperature of >38.0 degrees C at the time of screening.
• Have evidence of drug or alcohol abuse, or positive urine screen for drugs of abuse.