Safety, Tolerability and Pharmacokinetic Profile of SYL1801 Eye Drops

Study Overview
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Brief Summary
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Study of the safety, tolerability and pharmacokinetic profile of different doses of SYL1801 eye drops in healthy volunteers.

Official Title
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Safety, Tolerability and Pharmacokinetic Profile of Different Doses of SYL1801 Ophthalmic Solution in Healthy Volunteers

Conditions
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Safety, Tolerability and Pharmacokinetic Profile in Healthy Volunteers, Choroidal Neovascularization

Intervention / Treatment
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* Drug: SYL18001 sodium Low dose q.d
* Drug: SYL18001 sodium Middle dose q.d
* Drug: SYL18001 sodium High dose q.d
* Drug: SYL18001 sodium High dose b.i.d


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent Body mass index (BMI) between 19.5 and 29.0 kg/m2 Intraocular pressure (IOP) <=21 mmHg Best Corrected Visual Acuity (BCVA) >= 70 ETDRS Normal corneal and conjunctival assessment Normal funduscopy Exclusion Criteria: Pregnant or breastfeeding females or those with a positive pregnancy test. Females of childbearing potential who will not use a medically acceptable contraceptive method Current relevant diseases according to the investigator's judgement. Previous relevant chronic processes according to the investigator's judgement Relevant visual alterations according to the investigator's judgement Administration of systemic medications Case history of hypersensitivity to medicinal products or any other allergic process Participation in any clinical study with an investigational drug/device within 3 months prior to the first day of dosing.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Interventional, observer-masked, parallel groups, time-lagged trial to study safety, tolerability and PK of SYL1801 sodium in healthy volunteers.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single administration Low Dose once daily<br>1 treatment day | Drug: SYL18001 sodium Low dose q.d<br>* 1 drop in the randomized eye once daily<br>|
| Experimental: Single administration Middle Dose once daily<br>1 treatment day | Drug: SYL18001 sodium Middle dose q.d<br>* 1 drop in the randomized eye once daily<br>|
| Experimental: Single administration High Dose once daily<br>1 treatment day | Drug: SYL18001 sodium High dose q.d<br>* 1 drop in the randomized eye once daily<br>|
| Experimental: Single administration High Dose twice daily<br>1 treatment day | Drug: SYL18001 sodium High dose b.i.d<br>* 1 drop in the randomized eye twice daily<br>|
| Experimental: Multiple administrations Low Dose once daily<br>7 treatment days | Drug: SYL18001 sodium Low dose q.d<br>* 1 drop in the randomized eye once daily<br>|
| Experimental: Multiple administrations Middle Dose once daily<br>7 treatment days | Drug: SYL18001 sodium Middle dose q.d<br>* 1 drop in the randomized eye once daily<br>|
| Experimental: Multiple administrations High Dose once daily<br>7 treatment days | Drug: SYL18001 sodium High dose q.d<br>* 1 drop in the randomized eye once daily<br>|
| Experimental: Multiple administrations High Dose twice daily<br>7 treatment days | Drug: SYL18001 sodium High dose b.i.d<br>* 1 drop in the randomized eye twice daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oligonucleotide, siRNA (Small Interfering Ribonucleic Acid), Eye Drops, wet AMD (Age-related Macular Degeneration)