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Trial registered on ANZCTR


Registration number
ACTRN12624001355561
Ethics application status
Approved
Date submitted
21/09/2024
Date registered
12/11/2024
Date last updated
17/11/2024
Date data sharing statement initially provided
12/11/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
ILYX-002 Pharmacokinetics in Healthy Volunteers
Scientific title
A Study of the Multiple-Dose Pharmacokinetics of ILYX 002 in Healthy Volunteers
Secondary ID [1] 312990 0
ILYX-002-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dry-Eye Disease 335171 0
Condition category
Condition code
Eye 331663 331663 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ILYX-002 (0.3%) is a sterile, isotonic, preservative-free topical ophthalmic suspension. ILYX-002 will be administered by designated, unmasked site staff to the participant twice a day for 7 days plus a single dose in the morning on Day 8. The dosage is 1 drop in each eye per administration.

Participants will stay at the study center for a total of 9 days. Masked study treatment assignment will occur on Day 1 at the time of kit allocation. Each kit contains either ILYX-002 or vehicle, and there will be one kit assigned per participant. The Investigator, or designee, will be provided a group-specific, masked “Kit Allocation Scheme” that includes a randomly determined, prespecified list of kit identification numbers based on the number of eligible participants scheduled for each group. Allocation will occur in order based on the sequential confirmation of participant eligibility on Day 1 prior to dosing.

While residing at the study center, participants will receive their assigned study treatment (ILYX-002 or vehicle) approximately twice per day, be monitored closely for safety and tolerability, and have multiple, repeat blood draws. After discharge, participants will return for a final safety follow-up visit on Day 15. The total study duration will be up to 6 weeks, including a 4-week window for screening and determination of eligibility.
Intervention code [1] 329523 0
Treatment: Drugs
Comparator / control treatment
The vehicle is an ophthalmic suspension of the same composition as the intervention but does not contain any active drug substance. The vehicle control will be administered by designated, unmasked site staff to the participant twice a day for 7 days plus a single dose in the morning on Day 8. The dosage is 1 drop in each eye per administration.
Control group
Placebo

Outcomes
Primary outcome [1] 339390 0
To evaluate the pharmacokinetics of ILYX-002 (0.3%) compared to vehicle.
Timepoint [1] 339390 0
* Day 1: Pre-dose (in the morning) and 0.5, 1, 2, 4, 6, 12 hours post first dose
* Day 2: 24 hours post first dose
* Day 8: Pre-dose (AM) and 0.5, 1, 2, 4, 6, 12 hours post last dose
* Day 9: 24 hours post last dose
Primary outcome [2] 339606 0
To evaluate the pharmacokinetics of the investigational product’s active N-oxide metabolite compared to vehicle.
Timepoint [2] 339606 0
* Day 1: Pre-dose (in the morning) and 0.5, 1, 2, 4, 6, 12 hours post first dose
* Day 2: 24 hours post first dose
* Day 8: Pre-dose (AM) and 0.5, 1, 2, 4, 6, 12 hours post last dose
* Day 9: 24 hours post last dose
Secondary outcome [1] 439735 0
To evaluate the safety and tolerability of ILYX-002 (0.3%) compared to vehicle
Timepoint [1] 439735 0
* Any ocular and non-ocular events occurring from the time that the informed consent form is signed through the last day of participation in the study will be recorded and assessed.
* Corrected visual acuity will be assessed at screening, baseline (Day -1 or Day 1 prior to first study treatment), Days 2-9, and at the safety follow-up visit (Day 15).
* The slit lamp examination will be assessed at screening, baseline, 1 day post end of treatment (Day 9), and safety follow-up visit (Day 15).
* Intraocular pressure will be assessed at screening, baseline, and 1 day post end of treatment (Day 9).
* Dilated ophthalmoscopy will be assessed at screening and 1 day post end of treatment (Day 9).
* Participant-reported ocular discomfort based on 100-point VAS will be assessed at screening, baseline (Day 1 prior to treatment), during treatment (Day 2 and Day 8), 1 day post end of treatment (Day 9), and at the safety follow-up visit (Day 15).
* Participant-reported ocular tolerability based on 100-point VAS will be assessed right after study treatment administration on Day 1, Day 2, and Day 8 (end of treatment).

Eligibility
Key inclusion criteria
1. Male or female, 18 to 70 years of age
2. Must be in good general health
3. Body mass index greater than or equal to 18 and less than 35
4. Willing to discontinue use of alcohol, caffeine, tobacco, and cannabis at least 24 hours prior to and during the inpatient portion of the study
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Any history of severe ocular trauma in either eye
2. Current or recent history of ocular infection or inflammation in either eye within 3 months prior to screening
3. Within 15 days prior to screening have taken, used, or anticipate using contraindicated ophthalmic medications or devices
4. Anticipated use of contact lenses in either eye during the study
5. Ocular surface or anterior segment surgery within 1 year prior to screening
6. History of glaucoma or actively being treated for glaucoma
7. History of punctal cautery at any time in either eye
8. Positive alcohol breath and/or urine drug screen

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)
Masked study treatment assignment will occur on Day 1 at the time of kit allocation. Each kit contains either ILYX-002 or vehicle, and there will be one kit assigned per participant. Kits are labeled with a unique kit number in a manner that preserves masking. Kit allocation will be based on a masked "Kit Allocation Scheme" that lists the unique kit number to be assigned to a participant based on order of eligibility confirmation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/11/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 27101 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment postcode(s) [1] 43173 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 317426 0
Commercial sector/Industry
Name [1] 317426 0
Iolyx Australia Pty Ltd
Country [1] 317426 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Iolyx Australia Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 319713 0
None
Name [1] 319713 0
Address [1] 319713 0
Country [1] 319713 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316148 0
Bellberry Human Research Ethics Committee A
Ethics committee address [1] 316148 0
https://bellberry.com.au/
Ethics committee country [1] 316148 0
Australia
Date submitted for ethics approval [1] 316148 0
04/09/2024
Approval date [1] 316148 0
08/10/2024
Ethics approval number [1] 316148 0

Summary
Brief summary
This early phase study is to assess the pharmacokinetics (how the body processes a drug), safety, and tolerability of ILYX-002 administered as an eye drop. ILYX-002 is being developed as a potential treatment for Dry Eye Disease. In this study, approximately 16 generally healthy male and female adults will be enrolled. Fourteen will receive ILYX-002 and two will receive vehicle, which is an eye drop of similar makeup except no active drug substance. Participants will stay at the study center for a total of 9 days. While residing at the study center, participants will receive their assigned study treatment approximately twice per day, be monitored closely for safety and tolerability, and have multiple, repeat blood draws. After discharge, participants will return for a final safety follow-up visit on Day 15. The total study duration will be up to 6 weeks, including a 4-week window for screening and determination of eligibility.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136938 0
Dr Tony Le
Address 136938 0
CMAX Clinical Research Pty Ltd, Ground Floor, 21-24 North Terrace, Adelaide, South Australia, 5000
Country 136938 0
Australia
Phone 136938 0
+61 449 044 697
Fax 136938 0
Email 136938 0
[email protected]
Contact person for public queries
Name 136939 0
Tony Le
Address 136939 0
CMAX Clinical Research Pty Ltd, Ground Floor, 21-24 North Terrace, Adelaide, South Australia, 5000
Country 136939 0
Australia
Phone 136939 0
+61 449 044 697
Fax 136939 0
Email 136939 0
[email protected]
Contact person for scientific queries
Name 136940 0
Tony Le
Address 136940 0
CMAX Clinical Research Pty Ltd, Ground Floor, 21-24 North Terrace, Adelaide, South Australia, 5000
Country 136940 0
Australia
Phone 136940 0
+61 449 044 697
Fax 136940 0
Email 136940 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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.