Safety, Tolerability and Pharmacokinetic Profile of SYL1801 Eye Drops

• Status: Recruiting
• Trial end date: 2022-01-05
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sylentis, S.A.

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.