None listed
Conditions
Brief summary
This study will assess the safety and PK of single and multiple doses of the oral drug NP202 in healthy volunteers. Results from this study will help determine the development of NP202 as a treatment for preventing cardiac remodelling post acute myocardial infarction.
Interventions
NP202 oral capsules
Part A: 5 sequential cohorts of healthy volunteers each receiving a single dose of 50, 200, 600, 1000 or 1600mg and followed up to Day 7.
Part B: 3 cohorts of healthy volunteers each receiving one dose per day for 14 days, and followed up to Day 21. Dose levels to be determined after Part A is complete, based on review of Part A safety and PK data. Each cohort will have a single dose level.
All subjects (Parts A and B) will be resident in clinic for dosing. This will ensu
NP202 oral capsules Part A: 5 sequential cohorts of healthy volunteers each receiving a single dose of 50, 200, 600, 1000 or 1600mg and followed up to Day 7. Part B: 3 cohorts of healthy volunteers each receiving one dose per day for 14 days, and followed up to Day 21. Dose levels to be determined after Part A is complete, based on review of Part A safety and PK data. Each cohort will have a single dose level. All subjects (Parts A and B) will be resident in clinic for dosing. This will ensure dosing compliance. In each cohort 75% of subjects will receive NP202 and 25% will receive placebo.
Sponsors
NeuProtect Pty Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Subjects who; - Provide written informed consent. - Are male aged 18 to 45 years old inclusive at the time of consent. - Have a body mass index (BMI) <30 Kg/m2. - Have adequate venous access to allow collection of multiple blood samples during the study
Exclusion criteria
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.
Outcome results
None listed