Safety Tolerability and Pharmacokinetic Profile of SYL1801 Eye Drops

  • STATUS
    Recruiting
  • days left to enroll
    82
  • participants needed
    36
  • sponsor
    Sylentis, S.A.
Updated on 4 April 2021

Summary

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

Details
Condition Choroidal Neovascularization, Safety, Tolerability and Pharmacokinetic Profile in Healthy Volunteers, Safety, Tolerability and Pharmacokinetic Profile in Healthy Volunteers
Treatment SYL18001 sodium Low dose q.d, SYL18001 sodium Middle dose q.d, SYL18001 sodium High dose q.d, SYL18001 sodium High dose b.i.d
Clinical Study IdentifierNCT04782271
SponsorSylentis, S.A.
Last Modified on4 April 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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