Safety, Tolerability and Pharmacokinetic Profile in Healthy VolunteersPhase 1NCT04782271
Safety, Tolerability and Pharmacokinetic Profile of SYL1801 Eye Drops
A Phase 1 study testing SYL18001 sodium Low dose q.d, SYL18001 sodium Middle dose q.d and SYL18001 sodium High dose q.d in people with Safety, Tolerability and Pharmacokinetic Profile in Healthy Volunteers and Choroidal Neovascularization, run by Sylentis, S.A. at 1 site in Spain.
Trial summary
Study of the safety, tolerability and pharmacokinetic profile of different doses of SYL1801 eye drops in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety, Tolerability and Pharmacokinetic Profile in Healthy Volunteers, Choroidal Neovascularization
- What is being tested?
- SYL18001 sodium Low dose q.d, SYL18001 sodium Middle dose q.d and SYL18001 sodium High dose q.d
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- 17 Mar 2021to 21 Dec 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety, Tolerability and Pharmacokinetic Profile of Different Doses of SYL1801 Ophthalmic Solution in Healthy Volunteers
Study of the safety, tolerability and pharmacokinetic profile of different doses of SYL1801 eye drops in healthy volunteers.
- Conditions
- Safety, Tolerability and Pharmacokinetic Profile in Healthy Volunteers, Choroidal Neovascularization
- Being tested
- 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
- Keywords
- Oligonucleotide, siRNA (Small Interfering Ribonucleic Acid), Eye Drops, wet AMD (Age-related Macular Degeneration)
- Medical subject headings
- Choroidal Neovascularization, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYL18001 sodium Low dose q.dDrug
1 drop in the randomized eye once daily
SYL18001 sodium Middle dose q.dDrug
1 drop in the randomized eye once daily
SYL18001 sodium High dose q.dDrug
1 drop in the randomized eye once daily
SYL18001 sodium High dose b.i.dDrug
1 drop in the randomized eye twice daily
| Study group | Role | What they receive |
|---|---|---|
| Single administration Low Dose once daily | Experimental | 1 treatment day Receives: Drug: SYL18001 sodium Low dose q.d |
| Single administration Middle Dose once daily | Experimental | 1 treatment day Receives: Drug: SYL18001 sodium Middle dose q.d |
| Single administration High Dose once daily | Experimental | 1 treatment day Receives: Drug: SYL18001 sodium High dose q.d |
| Single administration High Dose twice daily | Experimental | 1 treatment day Receives: Drug: SYL18001 sodium High dose b.i.d |
| Multiple administrations Low Dose once daily | Experimental | 7 treatment days Receives: Drug: SYL18001 sodium Low dose q.d |
| Multiple administrations Middle Dose once daily | Experimental | 7 treatment days Receives: Drug: SYL18001 sodium Middle dose q.d |
| Multiple administrations High Dose once daily | Experimental | 7 treatment days Receives: Drug: SYL18001 sodium High dose q.d |
| Multiple administrations High Dose twice daily | Experimental | 7 treatment days Receives: Drug: SYL18001 sodium High dose b.i.d |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 72 hours after last instillation
Determination of the maximum Plasma Concentration [Cmax]
Measured: - 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]
Measured: - 15 - 30 minutes, 1- 4 and 24 hours after last administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start17 Mar 2021
- Primary completion21 Dec 2021
- Study completion21 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety, Tolerability and Pharmacokinetic Profile in Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Interventional, observer-masked, parallel groups, time-lagged trial to study safety, tolerability and PK of SYL1801 sodium in healthy volunteers.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sylentis, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782271
- Sponsor's protocol ID
- SYL1801_I
- Status last verified
- Mar 2022
- First submitted
- 1 Mar 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Pharmacokinetic Profile of Different Doses of SYL1801 Ophthalmic Solution in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04782271
- Acronym / sponsor ID
- SYL1801_I
- Conditions
- 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)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Sylentis, S.A.Industry (pharma, biotech, devices)
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- 21 Dec 2021 (actual)
- Study completion
- 21 Dec 2021 (actual)
- First posted
- 4 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study of the safety, tolerability and pharmacokinetic profile of different doses of SYL1801 eye drops in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 8
- Model description
- Interventional, observer-masked, parallel groups, time-lagged trial to study safety, tolerability and PK of SYL1801 sodium in healthy volunteers.
| Arm | Type | Receives |
|---|---|---|
| Single administration Low Dose once daily | Experimental | Drug: SYL18001 sodium Low dose q.d1 treatment day |
| Single administration Middle Dose once daily | Experimental | Drug: SYL18001 sodium Middle dose q.d1 treatment day |
| Single administration High Dose once daily | Experimental | Drug: SYL18001 sodium High dose q.d1 treatment day |
| Single administration High Dose twice daily | Experimental | Drug: SYL18001 sodium High dose b.i.d1 treatment day |
| Multiple administrations Low Dose once daily | Experimental | Drug: SYL18001 sodium Low dose q.d7 treatment days |
| Multiple administrations Middle Dose once daily | Experimental | Drug: SYL18001 sodium Middle dose q.d7 treatment days |
| Multiple administrations High Dose once daily | Experimental | Drug: SYL18001 sodium High dose q.d7 treatment days |
| Multiple administrations High Dose twice daily | Experimental | Drug: SYL18001 sodium High dose b.i.d7 treatment days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SYL18001 sodium Low dose q.d1 drop in the randomized eye once daily | Drug | Multiple administrations Low Dose once daily, Single administration Low Dose once daily |
| SYL18001 sodium Middle dose q.d1 drop in the randomized eye once daily | Drug | Multiple administrations Middle Dose once daily, Single administration Middle Dose once daily |
| SYL18001 sodium High dose q.d1 drop in the randomized eye once daily | Drug | Multiple administrations High Dose once daily, Single administration High Dose once daily |
| SYL18001 sodium High dose b.i.d1 drop in the randomized eye twice daily | Drug | Multiple administrations High Dose twice daily, Single administration High Dose twice daily |
Primary outcome
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
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
Determination of the maximum Plasma Concentration [Cmax]
Time frame: - 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]
Time frame: - 15 - 30 minutes, 1- 4 and 24 hours after last administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
Related trials for Safety, Tolerability and Pharmacokinetic Profile in Healthy Volunteers
RecruitingPhase 1
A Phase 1 Study of GZC8072 Tablets Following a Single Dose in Healthy Study Participants and Multiple Doses in Obese/Overweight Study Participants
Healthy Subjects;Overweight or Obesity
RecruitingPhase 1
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KL0011034 Injection in Healthy Volunteers
Healthy Volunteers
Not yet recruitingPhase 1
A Phase 1 Study of KHN707 Tablets in Healthy Participants
Healthy Adult Participants
Not yet recruitingPhase 1
Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic (PK/PD) Profile of ACT100 in Healthy Participants..
Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus
RecruitingPhase 1
A Study of UA026 Tablets in Healthy Adult Subjects and Adult Subjects With Moderate to Severe Plaque Psoriasis
Plaque Psoriasis, Healthy Volunteer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SYL18001 sodium Low dose q.d, SYL18001 sodium Middle dose q.d and SYL18001 sodium High dose q.d in people with Safety, Tolerability and Pharmacokinetic Profile in Healthy Volunteers and Choroidal Neovascularization, run by Sylentis, S.A. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.