Safety, Tolerability and Pharmacokinetic Profile of SYL1801 Eye Drops

Sylentis

Status and phase: Completed; Phase 1

Conditions: Choroidal Neovascularization; Safety, Tolerability and Pharmacokinetic Profile in Healthy Volunteers

Treatments: Drug: SYL18001 sodium Low dose q.d; Drug: SYL18001 sodium Middle dose q.d; Drug: SYL18001 sodium High dose q.d; Drug: SYL18001 sodium High dose b.i.d

Study type: Interventional

Funder types: Industry

Identifiers

NCT04782271

SYL1801_I

Details and patient eligibility

About

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

Enrollment: 36 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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36 participants in 8 patient groups

Single administration Low Dose once daily

Experimental group

Description:

1 treatment day

Treatment:

Drug: SYL18001 sodium Low dose q.d

Single administration Middle Dose once daily

Experimental group

Description:

1 treatment day

Treatment:

Drug: SYL18001 sodium Middle dose q.d

Single administration High Dose once daily

Experimental group

Description:

1 treatment day

Treatment:

Drug: SYL18001 sodium High dose q.d

Single administration High Dose twice daily

Experimental group

Description:

1 treatment day

Treatment:

Drug: SYL18001 sodium High dose b.i.d

Multiple administrations Low Dose once daily

Experimental group

Description:

7 treatment days

Treatment:

Drug: SYL18001 sodium Low dose q.d

Multiple administrations Middle Dose once daily

Experimental group

Description:

7 treatment days

Treatment:

Drug: SYL18001 sodium Middle dose q.d

Multiple administrations High Dose once daily

Experimental group

Description:

7 treatment days

Treatment:

Drug: SYL18001 sodium High dose q.d

Multiple administrations High Dose twice daily

Experimental group

Description:

7 treatment days

Treatment:

Drug: SYL18001 sodium High dose b.i.d