Choroidal Neovascularization, Safety, Tolerability and Pharmacokinetic Profile in Healthy Volunteers
Conditions
Keywords
Oligonucleotide, siRNA (Small Interfering Ribonucleic Acid), Eye Drops, wet AMD (Age-related Macular Degeneration)
Brief summary
Study of the safety, tolerability and pharmacokinetic profile of different doses of SYL1801 eye drops in healthy volunteers.
Interventions
DRUGSYL18001 sodium Low dose q.d
1 drop in the randomized eye once daily
DRUGSYL18001 sodium Middle dose q.d
1 drop in the randomized eye once daily
DRUGSYL18001 sodium High dose q.d
1 drop in the randomized eye once daily
DRUGSYL18001 sodium High dose b.i.d
1 drop in the randomized eye twice daily
Sponsors
Sylentis, S.A.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Interventional, observer-masked, parallel groups, time-lagged trial to study safety, tolerability and PK of SYL1801 sodium in healthy volunteers.
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | — |
Countries
Spain
Outcome results
None listed