A Phase I, randomised, double blind, placebo-controlled, dose-escalating study of the safety, tolerability, food effect and pharmacokinetics of single and repeat doses of OCX063 administered orally to healthy volunteers
- Conditions
- Fibrotic ocular diseasesInflammatory ocular diseasesEye - Diseases / disorders of the eye
- Registration Number
- ACTRN12619001607167
- Lead Sponsor
- OccuRx Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 64
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and tolerability will be assessed by vital signs, clinical safety labs, electrocardiograms (ECGs), physical exams and adverse events.[Part A and Part B: Daily in-patient monitoring for 3 days plus follow up visit on Day 8<br>Part C: Daily in-patient monitoring for 14 days plus follow up visit on Day 22]
- Secondary Outcome Measures
Name Time Method Plasma pharmacokinetics of OCX063, including AUC, Tmax, Cmax, T1/2[Part A and Part B: At 15, 30 minutes and 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post dose<br><br>Part C: At 15, 30 minutes and 1, 2, 3, 4, 6, 8, 12, and 24 hours post dose, on Day 1 and Day 14, prior to drug administration on Day 8, and on Day 22.];Urine pharmacokinetics of OCX063, including absorption and elimination[Part A and Part B: Pooled samples 0-4, 4-12, 12-24 hours post dose, and a spot urine sample at 24, 36, and 48 hours post dose<br><br>Part C: Pooled samples samples 0-4, 4-12, 12-24 hours post dose, on Day 1 and Day 14, and spot samples prior to drug administration on Day 8, and on Day 22.]