Safety, Tolerability and Pharmacokinetic Profile of SYL1801 Eye Drops

• Sponsor: Sylentis, S.A. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04782271
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 8
• Actual Duration (Months): 9.2
• Patients Per Site Per Month: 3.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Safety, Tolerability and Pharmacokinetic Profile in Healthy Volunteers; Choroidal Neovascularization	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	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Sequential Assignment
• Intervention Model Description: Interventional, observer-masked, parallel groups, time-lagged trial to study safety, tolerability and PK of SYL1801 sodium in healthy volunteers.Interventional, observer-masked, parallel groups, time-lagged trial to study safety, tolerability and PK of SYL1801 sodium in healthy volunteers.
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Safety, Tolerability and Pharmacokinetic Profile of Different Doses of SYL1801 Ophthalmic Solution in Healthy Volunteers
• Actual Study Start Date: Mar 17, 2021
• Actual Primary Completion Date: Dec 21, 2021
• Actual Study Completion Date: Dec 21, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single administration Low Dose once daily 1 treatment day	Drug: SYL18001 sodium Low dose q.d; 1 drop in the randomized eye once daily
Experimental: Single administration Middle Dose once daily 1 treatment day	Drug: SYL18001 sodium Middle dose q.d; 1 drop in the randomized eye once daily
Experimental: Single administration High Dose once daily 1 treatment day	Drug: SYL18001 sodium High dose q.d; 1 drop in the randomized eye once daily
Experimental: Single administration High Dose twice daily 1 treatment day	Drug: SYL18001 sodium High dose b.i.d; 1 drop in the randomized eye twice daily
Experimental: Multiple administrations Low Dose once daily 7 treatment days	Drug: SYL18001 sodium Low dose q.d; 1 drop in the randomized eye once daily
Experimental: Multiple administrations Middle Dose once daily 7 treatment days	Drug: SYL18001 sodium Middle dose q.d; 1 drop in the randomized eye once daily
Experimental: Multiple administrations High Dose once daily 7 treatment days	Drug: SYL18001 sodium High dose q.d; 1 drop in the randomized eye once daily
Experimental: Multiple administrations High Dose twice daily 7 treatment days	Drug: SYL18001 sodium High dose b.i.d; 1 drop in the randomized eye twice daily

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. Determination of the maximum Plasma Concentration [Cmax] [- 15 - 30 minutes, 1- 4 and 24 hours after last administration]

4. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sylentis Clinical Trial Site	Madrid		Spain	28034

Sponsors and Collaborators

• Sylentis, S.A.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sylentis, S.A.
• ClinicalTrials.gov Identifier: NCT04782271
• Other Study ID Numbers: SYL1801_I
• First Posted: Mar 4, 2021
• Last Update Posted: Mar 31, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sylentis, S.A.: Oligonucleotide; siRNA (Small Interfering Ribonucleic Acid); Eye Drops; wet AMD (Age-related Macular Degeneration)
• Additional relevant MeSH terms: Choroidal Neovascularization; Neovascularization, Pathologic

Study Results

No Results Posted as of Mar 31, 2022