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Completed

NCT Number: NCT04782271

Safety, Tolerability and Pharmacokinetic Profile of SYL1801 Eye Drops

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

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Key information

Conditions

Safety, Tolerability and Pharmacokinetic Profile in Healthy Volunteers Choroid Diseases Choroidal Neovascularization Eye Diseases Macular Degeneration Metaplasia Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Uveal Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sylentis Clinical Trial Site

Madrid, 28034, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SYL18001 sodium Low dose q.d

Drug

1 drop in the randomized eye once daily

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

Primary outcomes

  1. 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

  2. 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

  3. Determination of the maximum Plasma Concentration [Cmax]

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

  4. 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

Sponsors and collaborators

Lead sponsor

Sylentis, S.A.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 4, 2021
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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