Safety, Tolerability and Pharmacokinetic Profile of SYL1801 Eye Drops

Phase 1

Completed

• Conditions: Safety, Tolerability and Pharmacokinetic Profile in Healthy Volunteers; Choroidal Neovascularization
• Interventions: Drug: SYL18001 sodium Middle dose q.d; Drug: SYL18001 sodium Low dose q.d; Drug: SYL18001 sodium High dose q.d; Drug: SYL18001 sodium High dose b.i.d

• Registration Number: NCT04782271
• Lead Sponsor: Sylentis, S.A.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-01
• Study First Submitted QC: 2021-03-03
• Study First Posted: 2021-03-04
• Study Start: 2021-03-17
• Primary Completion: 2021-12-21
• Study Completion: 2021-12-21
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-30
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Single administration Middle Dose once daily	SYL18001 sodium Middle dose q.d	1 treatment day
Multiple administrations Low Dose once daily	SYL18001 sodium Low dose q.d	7 treatment days
Multiple administrations High Dose once daily	SYL18001 sodium High dose q.d	7 treatment days
Single administration Low Dose once daily	SYL18001 sodium Low dose q.d	1 treatment day
Multiple administrations Middle Dose once daily	SYL18001 sodium Middle dose q.d	7 treatment days
Multiple administrations High Dose twice daily	SYL18001 sodium High dose b.i.d	7 treatment days
Single administration High Dose once daily	SYL18001 sodium High dose q.d	1 treatment day
Single administration High Dose twice daily	SYL18001 sodium High dose b.i.d	1 treatment day

Primary Outcome Measures

Name	Time	Method
Determination of the Area Under the Curve of plasma concentrations until the last extraction time [AUT 0-t]	- 15 - 30 minutes, 1- 4 and 24 hours after last administration
Ocular tolerability at the site of administration (cornea and conjunctiva) after last instillation of the assigned dose level (1 day of treatment).	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).	72 hours after last instillation	Slit lamp evaluation
Determination of the maximum Plasma Concentration [Cmax]	- 15 - 30 minutes, 1- 4 and 24 hours after last administration

Trial Locations

Locations (1)

Sylentis Clinical Trial Site; 🇪🇸 Madrid, Spain