Safety, Tolerability and Pharmacokinetic Profile of SYL1801 Eye Drops

March 30, 2022 updated by: Sylentis, S.A.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28034
        • Sylentis Clinical Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

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).
Time Frame: 72 hours after last instillation
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).
Time Frame: 72 hours after last instillation
Slit lamp evaluation
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
- 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
- 15 - 30 minutes, 1- 4 and 24 hours after last administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sylentis, S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2021

Primary Completion (Actual)

December 21, 2021

Study Completion (Actual)

December 21, 2021

Study Registration Dates

First Submitted

March 1, 2021

First Submitted That Met QC Criteria

March 3, 2021

First Posted (Actual)

March 4, 2021

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 30, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYL1801_I

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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