Safety, Tolerability and Pharmacokinetic Profile of SYL1801 Eye Drops
Safety, Tolerability and Pharmacokinetic Profile in Healthy Volunteers, Choroidal Neovascularization
About this trial
This is an interventional treatment trial for Safety, Tolerability and Pharmacokinetic Profile in Healthy Volunteers focused on measuring Oligonucleotide, siRNA (Small Interfering Ribonucleic Acid), Eye Drops, wet AMD (Age-related Macular Degeneration)
Eligibility Criteria
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.
Sites / Locations
- Sylentis Clinical Trial Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Single administration Low Dose once daily
Single administration Middle Dose once daily
Single administration High Dose once daily
Single administration High Dose twice daily
Multiple administrations Low Dose once daily
Multiple administrations Middle Dose once daily
Multiple administrations High Dose once daily
Multiple administrations High Dose twice daily
1 treatment day
1 treatment day
1 treatment day
1 treatment day
7 treatment days
7 treatment days
7 treatment days
7 treatment days