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Safety, Tolerability and Pharmacokinetic Profile of SYL1801 Eye Drops

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ClinicalTrials.gov Identifier: NCT04782271
Recruitment Status : Recruiting
First Posted : March 4, 2021
Last Update Posted : March 29, 2021
Sponsor:
Information provided by (Responsible Party):
Sylentis, S.A.

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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 : March 17, 2021
Estimated Primary Completion Date : January 3, 2022
Estimated Study Completion Date : January 5, 2022

Resource links provided by the National Library of Medicine


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




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). [ Time Frame: 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). [ Time Frame: 72 hours after last instillation ]
    Slit lamp evaluation

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


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04782271


Contacts
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Contact: Regulatory Affairs Department 918047667 info@sylentis.com

Locations
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Spain
Sylentis Clinical Trial Site Recruiting
Madrid, Spain, 28034
Contact: Regulatory Affairs Department       info@sylentis.com   
Sponsors and Collaborators
Sylentis, S.A.
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Responsible Party: Sylentis, S.A.
ClinicalTrials.gov Identifier: NCT04782271    
Other Study ID Numbers: SYL1801_I
First Posted: March 4, 2021    Key Record Dates
Last Update Posted: March 29, 2021
Last Verified: March 2021

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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:
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Choroidal Neovascularization
Neovascularization, Pathologic
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases
Eye Diseases