Status:
COMPLETED
Safety, Tolerability and Pharmacokinetic Profile of SYL1801 Eye Drops
Lead Sponsor:
Sylentis, S.A.
Conditions:
Safety, Tolerability and Pharmacokinetic Profile in Healthy Volunteers
Choroidal Neovascularization
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
Study of the safety, tolerability and pharmacokinetic profile of different doses of SYL1801 eye drops in healthy volunteers.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2021
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04782271
Start Date
March 17 2021
End Date
December 21 2021
Last Update
March 31 2022
Active Locations (1)
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1
Sylentis Clinical Trial Site
Madrid, Spain, 28034