Safety, Tolerability and Pharmacokinetic Profile of SYL1801 Eye Drops

Overview

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

Full Title of Study: “Safety, Tolerability and Pharmacokinetic Profile of Different Doses of SYL1801 Ophthalmic Solution in Healthy Volunteers”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Sequential Assignment
  • Primary Purpose: Treatment
  • Masking: Single (Outcomes Assessor)
• Study Primary Completion Date: December 21, 2021

Interventions

• Drug: SYL18001 sodium Low dose q.d
  • 1 drop in the randomized eye once daily
• Drug: SYL18001 sodium Middle dose q.d
  • 1 drop in the randomized eye once daily
• Drug: SYL18001 sodium High dose q.d
  • 1 drop in the randomized eye once daily
• Drug: SYL18001 sodium High dose b.i.d
  • 1 drop in the randomized eye twice daily

Arms, Groups and Cohorts

• Experimental: Single administration Low Dose once daily
  • 1 treatment day
• Experimental: Single administration Middle Dose once daily
  • 1 treatment day
• Experimental: Single administration High Dose once daily
  • 1 treatment day
• Experimental: Single administration High Dose twice daily
  • 1 treatment day
• Experimental: Multiple administrations Low Dose once daily
  • 7 treatment days
• Experimental: Multiple administrations Middle Dose once daily
  • 7 treatment days
• Experimental: Multiple administrations High Dose once daily
  • 7 treatment days
• Experimental: Multiple administrations High Dose twice daily
  • 7 treatment days

Clinical Trial Outcome Measures

Primary Measures

• 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
• 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
• Determination of the maximum Plasma Concentration [Cmax]
  • Time Frame: – 15 – 30 minutes, 1- 4 and 24 hours after last administration
• 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Sylentis, S.A.
• Provider of Information About this Clinical Study
  • Sponsor