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Safety, Tolerability and Pharmacokinetic Profile of SYL1801 Eye Drops

Primary Purpose

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

Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
SYL18001 sodium Low dose q.d
SYL18001 sodium Middle dose q.d
SYL18001 sodium High dose q.d
SYL18001 sodium High dose b.i.d
Sponsored by
Sylentis, S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Safety, Tolerability and Pharmacokinetic Profile in Healthy Volunteers focused on measuring Oligonucleotide, siRNA (Small Interfering Ribonucleic Acid), Eye Drops, wet AMD (Age-related Macular Degeneration)

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts 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.

Sites / Locations

  • Sylentis Clinical Trial Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Single administration Low Dose once daily

Single administration Middle Dose once daily

Single administration High Dose once daily

Single administration High Dose twice daily

Multiple administrations Low Dose once daily

Multiple administrations Middle Dose once daily

Multiple administrations High Dose once daily

Multiple administrations High Dose twice daily

Arm Description

1 treatment day

1 treatment day

1 treatment day

1 treatment day

7 treatment days

7 treatment days

7 treatment days

7 treatment days

Outcomes

Primary Outcome Measures

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
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
Determination of the maximum Plasma Concentration [Cmax]
Determination of the Area Under the Curve of plasma concentrations until the last extraction time [AUT 0-t]

Secondary Outcome Measures

Full Information

First Posted
March 1, 2021
Last Updated
March 30, 2022
Sponsor
Sylentis, S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT04782271
Brief Title
Safety, Tolerability and Pharmacokinetic Profile of SYL1801 Eye Drops
Official Title
Safety, Tolerability and Pharmacokinetic Profile of Different Doses of SYL1801 Ophthalmic Solution in Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
March 17, 2021 (Actual)
Primary Completion Date
December 21, 2021 (Actual)
Study Completion Date
December 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sylentis, S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Safety, Tolerability and Pharmacokinetic Profile in Healthy Volunteers, Choroidal Neovascularization
Keywords
Oligonucleotide, siRNA (Small Interfering Ribonucleic Acid), Eye Drops, wet AMD (Age-related Macular Degeneration)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Interventional, observer-masked, parallel groups, time-lagged trial to study safety, tolerability and PK of SYL1801 sodium in healthy volunteers.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single administration Low Dose once daily
Arm Type
Experimental
Arm Description
1 treatment day
Arm Title
Single administration Middle Dose once daily
Arm Type
Experimental
Arm Description
1 treatment day
Arm Title
Single administration High Dose once daily
Arm Type
Experimental
Arm Description
1 treatment day
Arm Title
Single administration High Dose twice daily
Arm Type
Experimental
Arm Description
1 treatment day
Arm Title
Multiple administrations Low Dose once daily
Arm Type
Experimental
Arm Description
7 treatment days
Arm Title
Multiple administrations Middle Dose once daily
Arm Type
Experimental
Arm Description
7 treatment days
Arm Title
Multiple administrations High Dose once daily
Arm Type
Experimental
Arm Description
7 treatment days
Arm Title
Multiple administrations High Dose twice daily
Arm Type
Experimental
Arm Description
7 treatment days
Intervention Type
Drug
Intervention Name(s)
SYL18001 sodium Low dose q.d
Intervention Description
1 drop in the randomized eye once daily
Intervention Type
Drug
Intervention Name(s)
SYL18001 sodium Middle dose q.d
Intervention Description
1 drop in the randomized eye once daily
Intervention Type
Drug
Intervention Name(s)
SYL18001 sodium High dose q.d
Intervention Description
1 drop in the randomized eye once daily
Intervention Type
Drug
Intervention Name(s)
SYL18001 sodium High dose b.i.d
Intervention Description
1 drop in the randomized eye twice daily
Primary Outcome Measure Information:
Title
Ocular tolerability at the site of administration (cornea and conjunctiva) after last instillation of the assigned dose level (1 day of treatment).
Description
Slit lamp evaluation
Time Frame
72 hours after last instillation
Title
Ocular tolerability at the site of administration (cornea and conjunctiva) after last instillation of the assigned dose level (7 days of treatment).
Description
Slit lamp evaluation
Time Frame
72 hours after last instillation
Title
Determination of the maximum Plasma Concentration [Cmax]
Time Frame
- 15 - 30 minutes, 1- 4 and 24 hours after last administration
Title
Determination of the Area Under the Curve of plasma concentrations until the last extraction time [AUT 0-t]
Time Frame
- 15 - 30 minutes, 1- 4 and 24 hours after last administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Sylentis Clinical Trial Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain

12. IPD Sharing Statement

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Safety, Tolerability and Pharmacokinetic Profile of SYL1801 Eye Drops

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