Safety, Tolerability and Pharmacokinetic Profile of SYL1801 Eye Drops

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-17

Study Completion Date

2021-12-21

Brief Summary

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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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Detailed Description

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Conditions

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Safety, Tolerability and Pharmacokinetic Profile in Healthy Volunteers Choroidal Neovascularization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Interventional, observer-masked, parallel groups, time-lagged trial to study safety, tolerability and PK of SYL1801 sodium in healthy volunteers.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Intervention Type DRUG

1 drop in the randomized eye twice daily

Interventions

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SYL18001 sodium Low dose q.d

1 drop in the randomized eye once daily

Intervention Type DRUG

SYL18001 sodium Middle dose q.d

1 drop in the randomized eye once daily

Intervention Type DRUG

SYL18001 sodium High dose q.d

1 drop in the randomized eye once daily

Intervention Type DRUG

SYL18001 sodium High dose b.i.d

1 drop in the randomized eye twice daily

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes