Clinical trial • Phase I • Ophthalmology
DS101 for Diabetic retinopathy
Phase I trial of DS101 for Diabetic retinopathy. Randomised, placebo (placebo-controlled; dose and schedule not specified), adaptive. 12 participants.
Overview
- Trial Therapeutic Area
- Ophthalmology
- Trial Disease
- Diabetic retinopathy
- Trial Stage
- Phase I
Key dates
- Initial CTIS Submission Date
- 22-05-2025
- First CTIS Authorization Date
- 01-08-2025
Trial design
Randomised, placebo (placebo-controlled; dose and schedule not specified), adaptive Phase I trial across 1 site in Spain.
- Randomised
- Yes
- Comparator
- Placebo (placebo-controlled; dose and schedule not specified)
- Adaptive
- True - single and multiple ascending dose (dose-escalation) design stated; no specific escalation rules, interim analyses or stopping rules provided
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 12
Eligibility
Recruits 12 Vulnerable population not selected (isVulnerablePopulationSelected:false). Trial population: healthy volunteers (adult). No details on consent/assent procedures provided in the record..
- Vulnerable Population
- Vulnerable population not selected (isVulnerablePopulationSelected:false). Trial population: healthy volunteers (adult). No details on consent/assent procedures provided in the record.
Recruitment
- Planned Sample Size
- 12
- Recruitment Window Months
- 7
- Consent Approach
- Informed consent expected from adult participants (healthy volunteers); no assent procedures, age-specific consent documents or languages specified in the record.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 12
Spain
- Earliest CTIS Part Ii Submission Date
- 21-05-2025
- Latest Decision Or Authorization Date
- 01-08-2025
- Processing Time Days
- 72
- Number Of Sites
- 1
- Number Of Participants
- 12
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Ophthalmology Service
- Contact Person Name
- Miguel Ángel Zapata
- Contact Person Email
- miguelangel.zapata@vallhebron.cat
- Number Of Participants
- 12
Sponsor
Primary sponsor
- Full Name
- Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
- Organisation Type
- Laboratory/Research/Testing facility
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- DS101
- Routes Of Administration
- Topical ocular
- Route
- ocular (topical)
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