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Study of the safety, tolerability and pharmacokinetic profile of different doses of SYL1801 eye drops in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single administration Low Dose once daily | Experimental | 1 treatment day |
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| Single administration Middle Dose once daily | Experimental | 1 treatment day |
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| Single administration High Dose once daily | Experimental | 1 treatment day |
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| Single administration High Dose twice daily | Experimental | 1 treatment day |
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| Multiple administrations Low Dose once daily | Experimental | 7 treatment days |
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| Multiple administrations Middle Dose once daily | Experimental | 7 treatment days |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYL18001 sodium Low dose q.d | Drug | 1 drop in the randomized eye once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ocular tolerability at the site of administration (cornea and conjunctiva) after last instillation of the assigned dose level (1 day of treatment). | Slit lamp evaluation | 72 hours after last instillation |
| Ocular tolerability at the site of administration (cornea and conjunctiva) after last instillation of the assigned dose level (7 days of treatment). | Slit lamp evaluation | 72 hours after last instillation |
| Determination of the maximum Plasma Concentration [Cmax] | - 15 - 30 minutes, 1- 4 and 24 hours after last administration | |
| Determination of the Area Under the Curve of plasma concentrations until the last extraction time [AUT 0-t] | - 15 - 30 minutes, 1- 4 and 24 hours after last administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sylentis Clinical Trial Site | Madrid | 28034 | Spain |
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Interventional, observer-masked, parallel groups, time-lagged trial to study safety, tolerability and PK of SYL1801 sodium in healthy volunteers.
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| Multiple administrations High Dose once daily | Experimental | 7 treatment days |
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| Multiple administrations High Dose twice daily | Experimental | 7 treatment days |
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| SYL18001 sodium Middle dose q.d | Drug | 1 drop in the randomized eye once daily |
|
| SYL18001 sodium High dose q.d | Drug | 1 drop in the randomized eye once daily |
|
| SYL18001 sodium High dose b.i.d | Drug | 1 drop in the randomized eye twice daily |
|
| ID | Term |
|---|---|
| D020256 | Choroidal Neovascularization |
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
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