NCT04782271

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

March 17, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2021

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

9 months

First QC Date

March 1, 2021

Last Update Submit

March 30, 2022

Conditions

Safety, Tolerability and Pharmacokinetic Profile in Healthy VolunteersChoroidal Neovascularization

Keywords

OligonucleotidesiRNA (Small Interfering Ribonucleic Acid)Eye Dropswet AMD (Age-related Macular Degeneration)

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

Study Arms (8)

Single administration Low Dose once daily

EXPERIMENTAL

1 treatment day

Drug: SYL18001 sodium Low dose q.d

Single administration Middle Dose once daily

EXPERIMENTAL

1 treatment day

Drug: SYL18001 sodium Middle dose q.d

Single administration High Dose once daily

EXPERIMENTAL

1 treatment day

Drug: SYL18001 sodium High dose q.d

Single administration High Dose twice daily

EXPERIMENTAL

1 treatment day

Drug: SYL18001 sodium High dose b.i.d

Multiple administrations Low Dose once daily

EXPERIMENTAL

7 treatment days

Drug: SYL18001 sodium Low dose q.d

Multiple administrations Middle Dose once daily

EXPERIMENTAL

7 treatment days

Drug: SYL18001 sodium Middle dose q.d

Multiple administrations High Dose once daily

EXPERIMENTAL

7 treatment days

Drug: SYL18001 sodium High dose q.d

Multiple administrations High Dose twice daily

EXPERIMENTAL

7 treatment days

Drug: SYL18001 sodium High dose b.i.d

Interventions

SYL18001 sodium Low dose q.dDRUG

1 drop in the randomized eye once daily

Multiple administrations Low Dose once dailySingle administration Low Dose once daily
SYL18001 sodium Middle dose q.dDRUG

1 drop in the randomized eye once daily

Multiple administrations Middle Dose once dailySingle administration Middle Dose once daily
SYL18001 sodium High dose q.dDRUG

1 drop in the randomized eye once daily

Multiple administrations High Dose once dailySingle administration High Dose once daily
SYL18001 sodium High dose b.i.dDRUG

1 drop in the randomized eye twice daily

Multiple administrations High Dose twice dailySingle administration High Dose twice daily

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sylentis Clinical Trial Site

Madrid, 28034, Spain

Location

MeSH Terms

Conditions

Choroidal NeovascularizationMacular Degeneration

Condition Hierarchy (Ancestors)

Choroid DiseasesUveal DiseasesEye DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and SymptomsRetinal DegenerationRetinal Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Interventional, observer-masked, parallel groups, time-lagged trial to study safety, tolerability and PK of SYL1801 sodium in healthy volunteers.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2021

First Posted

March 4, 2021

Study Start

March 17, 2021

Primary Completion

December 21, 2021

Study Completion

December 21, 2021

Last Updated

March 31, 2022

Record last verified: 2022-03

Locations

ES(1)