A 3-part Study of SYX-5219 in Healthy Volunteers and Participants With Atopic Dermatitis
22 april 2026 bijgewerkt door: Sitryx Therapeutics Ltd
A Multi-part, FiH Study in Healthy Participants and Participants With Atopic Dermatitis (AD) to Assess the Safety, Tolerability, Pharmacokinetics (PK) of Single & Multiple Ascending Doses and Selected Dose of SYX-5219 (AD Participants).
The purpose of this study is to evaluate the study drug, SYX-5219, in a multi-part First-in-Human (FiH) study to be conducted in healthy volunteers and participants with Atopic Dermatitis (AD). The objectives of this study are to determine the safety, tolerability and levels of SYX-5219 in the blood and urine when SYX-5219 is given in each part of the study (SAD, MAD, Food Effect and Participants with AD).
The study will be split into up to 3 parts as follows:
- Part 1 - Single Ascending Dose (SAD) and Food Effect in healthy volunteers
- Part 2 - Multiple Ascending Dose (MAD) in healthy volunteers
- Part 3 - Multiple Dose in Participants with AD - enrolling up to 45 males and females with a confirmed diagnosis of AD of at least 6 months, evaluating multiple dose administrations of SYX-5219 or placebo daily over a period of 42 days.
Studie Overzicht
Toestand
Werving
Interventie / Behandeling
Gedetailleerde beschrijving
This is a multi-part, adaptive, Phase 1, double-blind, first-in-human study to evaluate the safety, tolerability, and pharmacokinetics of SYX-5219 following single ascending doses (SAD), multiple ascending doses (MAD), and selected dosing in participants with atopic dermatitis (AD).
Parts 1 and 2 will be conducted at a single site in the UK. Part 3 will be conducted globally at multiple sites.
Part 1 (Single Ascending Dose & Food Effect) Part 1 (SAD) will enrol up to 48 healthy participants in cohorts (3:1, active:placebo). Participants will receive single doses of SYX-5219, with a food effect evaluation including a second dosing period following washout.
Part 2 (Multiple Ascending Dose) Part 2 (MAD) will enrol up to 24 healthy participants in cohorts (3:1, active:placebo). Participants will receive multiple doses of SYX-5219 over a defined treatment period.
Part 3 (AD Participants) Part 3 will enrol up to 45 participants with AD across multiple global sites. Participants will be randomised (2:1) to receive SYX-5219 or placebo for up to 42 days. Prior exposure to targeted systemic therapy will be limited. Study assessments will include safety and exploratory efficacy evaluations during treatment and follow-up.
Studietype
Ingrijpend
Inschrijving (Geschat)
149
Fase
- Fase 1
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Sitryx Therapeutics
- Telefoonnummer: +44 (0)1865 648401
- E-mail: info@sitryx.com
Studie Contact Back-up
- Naam: Sitryx Therapeutics
- Telefoonnummer: +44 (0) 1865 648401
- E-mail: info@sitryx.com
Studie Locaties
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Sofia, Bulgarije, 1404
- Werving
- Sitryx Clinical Site
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Herlev
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Herlev, Herlev, Denemarken, 2730
- Nog niet aan het werven
- Sitryx Clinical Site
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Berlin, Duitsland, 10117
- Werving
- Sitryx Clinical Site
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Frankfurt, Duitsland, 60596
- Werving
- Sitryx Clinical Site
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Freiburg im Breisgau, Duitsland, 79106
- Actief, niet wervend
- Sitryx Clinical Site
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Dublin, Ierland, D08 NHY1
- Werving
- Sitryx Clinical Site
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Manchester, Verenigd Koninkrijk, M23 9QZ
- Werving
- Sitryx Clinical Site
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Merthyr Tydfil, Verenigd Koninkrijk, CF48 4DR
- Werving
- Sitryx Clinical Site
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Arkansas
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Arkansas City, Arkansas, Verenigde Staten, 72117
- Werving
- Sitryx Clinical Site
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California
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Fremont, California, Verenigde Staten, 94538
- Werving
- Sitryx Clinical Site
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Indiana
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Plainfield, Indiana, Verenigde Staten, 46168
- Werving
- Sitryx Clinical Site
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Ohio
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Boardman, Ohio, Verenigde Staten, 44512
- Werving
- Sitryx Clinical Site
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Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19103
- Werving
- Sitryx Clinical Site
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Utah
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Bountiful, Utah, Verenigde Staten, 84010
- Werving
- Sitryx Clinical Site
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Ja
Beschrijving
Inclusion Criteria:
Parts 1 & 2
- Healthy male and female participant, between ≥ 18 to ≤ 65 years of age, inclusive, with a BMI of body mass index (BMI) of 18-32 kg/m2.
- Female participant of non-childbearing potential or female of childbearing potential that is sexually abstinent.
- No clinically significant abnormalities in laboratory, vital signs or ECG measurements.
Part 3
- Male and female participants with clinically confirmed diagnosis of active AD, between ≥ 18 to ≤ 65 years of age, inclusive, with a BMI of body mass index (BMI) of ≤40 kg/m2.
Meet minimum AD entry criteria;
- AD covering ≥10% of the body surface area (BSA) at screening and baseline.
- Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline.
- Validated Investigator's Global Assessment (vIGA) score of ≥ 3 (moderate) at screening and baseline.
- Peak Pruritus NRS score of ≥ 4 at screening and baseline.
Exclusion Criteria:
Parts 1 & 2
• Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 35 days or 5 half-lives (whichever is longer) prior to the first dose of IMP.
Part 3
- Any clinically significant medical condition or physical/laboratory/ECG/vital signs abnormality that would, in the opinion of the Investigator, put the participant at undue risk.
- Has medical history as stated in the main study exclusion criteria.
- Received treatment(s) as stated in the main study exclusion criteria.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Sequentiële toewijzing
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Part 1 Single Ascending Dose (SAD)
Single dose of SYX-5219 (active or matching placebo) administered on Day 1 for all cohorts and Day 1 of each treatment period for food effect cohorts (in fasted and fed conditions).
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Oral Capsule to be administered at each specific dose level within each cohort
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Experimenteel: Part 2 Multiple Ascending Dose (MAD)
Multiple doses of SYX-5219 (active or matching placebo) administered once or twice daily for all cohorts.
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Oral Capsule to be administered at each specific dose level within each cohort
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Experimenteel: Part 3 AD Participants Multiple Doses
Multiple doses of SYX-5219 (active or matching placebo) administered twice daily for multiple dose administration
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Oral Capsule to be administered at each specific dose level within each cohort
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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The Proportion of Participants With Treatment-Emergent Adverse Events
Tijdsspanne: Adverse events are collected from the date of consent until up to 10 days after the dose in Part 1 (Day 11), 14 days after the last dose in Part 2 (Day 28) and up to Day 56 in Part 3.
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The number of participants who reported a treatment-emergent adverse event (TEAE) will be summarised.
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Adverse events are collected from the date of consent until up to 10 days after the dose in Part 1 (Day 11), 14 days after the last dose in Part 2 (Day 28) and up to Day 56 in Part 3.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Concentrations of SYX5219 in Plasma
Tijdsspanne: For Part 1: 14 timepoints from pre-dose Day 1 up to 120 h post-dose Day 6. For Part 2: 28 timepoints from pre-dose Day 1 up to Day 19. For Part 3: 8 timepoints from pre-dose Day 1 up to Day 56.
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Plasma samples were obtained in order to evaluate defined plasma pharmacokinetic parameters for SYX-5219.
This endpoint will report the summary of derived pharmacokinetic parameters for participants in all parts of the study.
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For Part 1: 14 timepoints from pre-dose Day 1 up to 120 h post-dose Day 6. For Part 2: 28 timepoints from pre-dose Day 1 up to Day 19. For Part 3: 8 timepoints from pre-dose Day 1 up to Day 56.
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Concentrations of SYX5219 in Urine
Tijdsspanne: For Part 1: continuous urine collection from Day 1 up to 48 hr post-dose on Day 2. For Part 2: continuous urine collection from Day 1 up to 48 hr post-dose on Day 2 and Day 14 up to 48 hr post-dose on Day 16.
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Urine samples were obtained in order to evaluate defined urine pharmacokinetic parameters for SYX-5219.
This endpoint will report the summary of derived pharmacokinetic parameters for participants in Part 1 and Part 2 of the study.
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For Part 1: continuous urine collection from Day 1 up to 48 hr post-dose on Day 2. For Part 2: continuous urine collection from Day 1 up to 48 hr post-dose on Day 2 and Day 14 up to 48 hr post-dose on Day 16.
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Andere uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Percent change from baseline in the Eczema Area and Severity Index (EASI) - Part 3
Tijdsspanne: For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
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For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
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Proportion of participants achieving a 50% 75% and 90% reduction of EASI (EASI50 and EASI75 and EASI90) - Part 3
Tijdsspanne: For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
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For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
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Proportion of participants achieving a minimum 2- grade improvement from baseline in validated Investigator Global Assessment (vIGA) score to clear (0) or almost clear (1) - Part 3
Tijdsspanne: For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
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For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
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Percent change from baseline in peak pruritus numeric rating scale (PP-NRS) - Part 3
Tijdsspanne: For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
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For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
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Proportion of participants with ≥3-point and ≥4-point improvement in peak pruritus numeric rating scale - Part 3
Tijdsspanne: For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
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For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
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Percent change from baseline in weekly average of the daily PP-NRS scores - Part 3
Tijdsspanne: For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
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For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
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Percent change from baseline in weekly average of the daily sleep loss scores - Part 3
Tijdsspanne: For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
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For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
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Change from baseline and percent change from baseline in percent atopic dermatitis covering the body surface area (BSA) involvement - Part 3
Tijdsspanne: For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
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For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
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Change from baseline in Dermatology Life Quality Index (DLQI) - Part 3
Tijdsspanne: For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
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For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
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Change from baseline in Patient Orientated Eczema Measure (POEM) - Part 3
Tijdsspanne: For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
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For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: Sitryx Therapeutics, Study Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
26 februari 2025
Primaire voltooiing (Geschat)
30 augustus 2026
Studie voltooiing (Geschat)
30 september 2026
Studieregistratiedata
Eerst ingediend
22 april 2026
Eerst ingediend dat voldeed aan de QC-criteria
22 april 2026
Eerst geplaatst (Werkelijk)
30 april 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
30 april 2026
Laatste update ingediend die voldeed aan QC-criteria
22 april 2026
Laatst geverifieerd
1 april 2026
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- SYX-5219-101
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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