Safety, Tolerability and Pharmacokinetic Profile of SYL1801 Eye Drops

Sylentis, S.A.36 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Safety, Tolerability and Pharmacokinetic Profile in Healthy Volunteers Choroidal Neovascularization

Interventions

SYL18001 sodium Low dose q.dDRUG

1 drop in the randomized eye once daily

SYL18001 sodium Middle dose q.dDRUG

1 drop in the randomized eye once daily

SYL18001 sodium High dose q.dDRUG

1 drop in the randomized eye once daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Sylentis Clinical Trial Site

Madrid, Spain

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 72 hours after last instillation

Determination of the maximum Plasma Concentration [Cmax]

Time frame: - 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]

Time frame: - 15 - 30 minutes, 1- 4 and 24 hours after last administration

Data from ClinicalTrials.gov

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