Clinical trial • Phase I • Ophthalmology
ladarixin for Ocular inflammatory conditions | Eye inflammation
Phase I trial of ladarixin for Ocular inflammatory conditions | Eye inflammation. adaptive. 16 participants.
Overview
- Trial Therapeutic Area
- Ophthalmology
- Trial Disease
- Ocular inflammatory conditions | Eye inflammation
- Trial Stage
- Phase I
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 15-12-2025
- First CTIS Authorization Date
- 09-02-2026
Trial design
adaptive Phase I trial across 1 site in Netherlands.
- Adaptive
- True, single and multiple ascending dose (dose-escalation) design; specific escalation rules, interim analyses or stopping rules not provided
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 16
Eligibility
Recruits 16 Vulnerable population selected (isVulnerablePopulationSelected = true); no further details on consent/assent handling provided in the source..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true); no further details on consent/assent handling provided in the source.
Recruitment
- Planned Sample Size
- 16
- Recruitment Window Months
- 3
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 16
Netherlands
- Earliest CTIS Part Ii Submission Date
- 02-02-2026
- Latest Decision Or Authorization Date
- 09-02-2026
- Processing Time Days
- 7
- Number Of Sites
- 1
- Number Of Participants
- 16
Sites
- Site Name
- Pharmaceutical Research Associates Group B.V.
- Department Name
- Program Management
- Contact Person Name
- Maria Velinova
- Contact Person Email
- maria.velinova@iconplc.com
Sponsor
Primary sponsor
- Full Name
- Dompe' Farmaceutici S.p.A.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Italy
Contract research organisations
- Name
- Pharmaceutical Research Associates Group B.V.
- Responsibilities
- Listed as trial site organisation; Program Management contact (contact person: Maria Velinova, email: maria.velinova@iconplc.com)
Investigational products
- Investigational Product Name
- topical ladarixin ophthalmic solution
- Active Substance
- ladarixin
- Modality
- Small molecule
- Routes Of Administration
- Topical (ophthalmic)
- Route
- Topical (ophthalmic)
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