Safety, Tolerability and Pharmacokinetic Profile of SYL1801 Eye Drops

Choroidal Neovascularization Clinical Trial

Official title:

Safety, Tolerability and Pharmacokinetic Profile of Different Doses of SYL1801 Ophthalmic Solution in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04782271
• Other study ID #: SYL1801_I
• Status: Completed
• Phase: Phase 1
• Start date: March 17, 2021
• Est. completion date: December 21, 2021

Study information

• Verified date: March 2022
• Source: Sylentis, S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 21, 2021
• Est. primary completion date: December 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Neovascularization, Pathologic
• Safety, Tolerability and Pharmacokinetic Profile in Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
Spain	Sylentis Clinical Trial Site	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Sylentis, S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular tolerability at the site of administration (cornea and conjunctiva) after last instillation of the assigned dose level (1 day of treatment).	Slit lamp evaluation	72 hours after last instillation
Primary	Ocular tolerability at the site of administration (cornea and conjunctiva) after last instillation of the assigned dose level (7 days of treatment).	Slit lamp evaluation	72 hours after last instillation
Primary	Determination of the maximum Plasma Concentration [Cmax]		- 15 - 30 minutes, 1- 4 and 24 hours after last administration
Primary	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