Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001607167
Ethics application status
Approved
Date submitted
7/11/2019
Date registered
21/11/2019
Date last updated
2/11/2020
Date data sharing statement initially provided
21/11/2019
Date results information initially provided
2/11/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 299376 0
Protocol OCC-OCX063-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fibrotic ocular diseases 314541 0
Inflammatory ocular diseases 315207 0
Condition category
Condition code
Eye 312888 312888 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 315640 0
Treatment: Drugs
Comparator / control treatment
Part A and Part B: Oral placebo capsules (microcellulose) administered once.
Part C: Oral placebo capsules (microcellulose) administered once a day for 14 days.
Control group
Placebo

Outcomes
Primary outcome [1] 321492 0
Safety and tolerability will be assessed by vital signs, clinical safety labs, electrocardiograms (ECGs), physical exams and adverse events.
Timepoint [1] 321492 0
Part A and Part B: Daily in-patient monitoring for 3 days plus follow up visit on Day 8
Part C: Daily in-patient monitoring for 14 days plus follow up visit on Day 22
Secondary outcome [1] 375132 0
Plasma pharmacokinetics of OCX063, including AUC, Tmax, Cmax, T1/2
Timepoint [1] 375132 0
Part A and Part B: At 15, 30 minutes and 1, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post dose

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.
Secondary outcome [2] 376888 0
Urine pharmacokinetics of OCX063, including absorption and elimination
Timepoint [2] 376888 0
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

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.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2020
Actual
21/01/2020
Date of last participant enrolment
Anticipated
Actual
1/06/2020
Date of last data collection
Anticipated
Actual
30/06/2020
Sample size
Target
64
Accrual to date
Final
64
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15123 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 28418 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 303892 0
Commercial sector/Industry
Name [1] 303892 0
OccuRx Pty Ltd
Country [1] 303892 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
OccuRx Pty Ltd
Address
Level 9/31 Queen Street
Melbourne VIC 3000
Country
Australia
Secondary sponsor category [1] 304039 0
None
Name [1] 304039 0
Address [1] 304039 0
Country [1] 304039 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304398 0
The Alfred Hospital Ethics Committee
Ethics committee address [1] 304398 0
55 Commercial Rd
Melbourne VIC 3004
Ethics committee country [1] 304398 0
Australia
Date submitted for ethics approval [1] 304398 0
20/11/2019
Approval date [1] 304398 0
18/12/2019
Ethics approval number [1] 304398 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96806 0
Dr Jason Lickliter
Address 96806 0
Nucleus Network
Level 1, 484 St Kilda Road
Melbourne VIC 3004
Country 96806 0
Australia
Phone 96806 0
+61 3 9076 8906
Fax 96806 0
Email 96806 0
[email protected]
Contact person for public queries
Name 96807 0
Ms Nicole Kruger
Address 96807 0
OccuRx Pty Ltd
Level 9/31 Queen Street
Melbourne VIC 3000
Country 96807 0
Australia
Phone 96807 0
+61 3 9657 0704
Fax 96807 0
Email 96807 0
[email protected]
Contact person for scientific queries
Name 96808 0
Ms Nicole Kruger
Address 96808 0
OccuRx Pty Ltd
Level 9/31 Queen Street
Melbourne VIC 3000
Country 96808 0
Australia
Phone 96808 0
+61 3 9657 0704
Fax 96808 0
Email 96808 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a phase 1 study in healthy volunteers to guide further development plans. Individual participant results are not useful to the participants or to others outside of the sponsor. Only aggregate data may be posted/published.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.