None listed
Conditions
Brief summary
This is a single-centre, randomised, double blind, single and multiple ascending dose study to assess the safety and pharmacokinetics (PK) of OCX063 in healthy volunteers. Part A: Single Ascending Dose (SAD) cohorts will assess the safety and tolerability of single doses of OCX063. Part B: One SAD cohort will return for an additional dose to determine the effect of food on OCX063 PK. Part C: Multiple Ascending Dose (MAD) cohorts will assess the safety and tolerability of multiple doses of OCX063, when administered daily for 14 days.
Interventions
Part A, single ascending doses: Oral OCX063 capsules administered once with water to in-patients after an overnight fast of 10 hours. The starting dose (Cohort 1) will be 10mg, and subsequent doses (Cohorts 2 to 5) will be decided based on safety and pharmacokinetic data. Maximum dose is expected to be 500mg.
Part B: Oral OCX063 capsules administered once with water to in-patients immediately after a high fat meal following an an overnight fast of 10 hours. The dose will be decided based o
Part A, single ascending doses: Oral OCX063 capsules administered once with water to in-patients after an overnight fast of 10 hours. The starting dose (Cohort 1) will be 10mg, and subsequent doses (Cohorts 2 to 5) will be decided based on safety and pharmacokinetic data. Maximum dose is expected to be 500mg. Part B: Oral OCX063 capsules administered once with water to in-patients immediately after a high fat meal following an an overnight fast of 10 hours. The dose will be decided based on Part A data, and the relevant Part A cohort will return for Part B.. Part C, multiple ascending doses: Oral OCX063 capsules administered with water to in-patients after an overnight fast of 10 hours, once a day for 14 days. The starting dose will be decided based on Part A and Part B data, and subsequent doses decided based on safety and pharmacokinetic data.
Sponsors
OccuRx 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
Participants who; - Provide written informed consent prior to any study procedures and agree to adhere to all protocol requirements. - Are male aged 18 to 45 years old inclusive at the time of consent. - Are in good general health without clinically significant medical history. - Have a body mass index (BMI) less than 30kg/m2. - Have negative Human Immunodeficiency Virus (HIV), Hepatitis B and Hepatitis C Screening test results. - Agree to practice effective contraception during the study period and for 2 months after their last dose of study drug.
Exclusion criteria
Participants who; - Have received any other study drug within 30 days or 5 half-lives prior to Screening (4 months if the previous drug was a new chemical entity), whichever is longer. - 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 study drug. - Have received blood products within 1 month prior to Screening. - Have a history of thyroidectomy or thyroid disease that required medication within the past 12 months. - Have had serious angioedema episodes within the previous 3 years or requiring angioedema medication in the previous two years. - 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 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 any other condition which in the view of the Investigator is likely to interfere with the study or put the subject at risk. - Have high risk behaviours for HIV or hepatitis B or C (i.e. injecting drug use, commercial sex work, unsafe sexual practices) - Have a history of or current clinically significant gastrointestinal, hepatic, renal, cardiovascular, respiratory, endocrine, oncological, immunodeficiency, neurological, metabolic, haematological or autoimmune disorder; or a history of or current tuberculosis, epilepsy, diabetes or glaucoma - Have clinical signs of active infection and/or a temperature of > 38.0°C at the time of Screening. Study entry may be deferred at the discretion of the Principal Investigator - Have a positive alcohol breath test or urine screen for drugs of abuse at Screening or check-in, or evidence of drug or alcohol abuse in the investigator’s opinion. - Are unable to provide a blood sample without undue trauma or distress. - Have any other medical condition or significant co-morbidities, or any finding during Screening, which may interfere with the study objectives in the investigator’s opinion. - Have a history of or current clinically relevant social, clinical, or psychiatric condition which, in the opinion of the investigator, makes the participant unsuitable for participation in the study
Outcome results
None listed