Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

A 3-part Study of SYX-5219 in Healthy Volunteers and Participants With Atopic Dermatitis

22. april 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Antatt)

149

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Sitryx Therapeutics
  • Telefonnummer: +44 (0)1865 648401
  • E-post: info@sitryx.com

Studer Kontakt Backup

  • Navn: Sitryx Therapeutics
  • Telefonnummer: +44 (0) 1865 648401
  • E-post: info@sitryx.com

Studiesteder

  • Bulgaria
      • Sofia, Bulgaria, 1404
        • Rekruttering
        • Sitryx Clinical Site
  • Danmark
    • Herlev
      • Herlev, Herlev, Danmark, 2730
        • Har ikke rekruttert ennå
        • Sitryx Clinical Site
  • Forente stater
    • Arkansas
      • Arkansas City, Arkansas, Forente stater, 72117
        • Rekruttering
        • Sitryx Clinical Site
    • California
      • Fremont, California, Forente stater, 94538
        • Rekruttering
        • Sitryx Clinical Site
    • Indiana
      • Plainfield, Indiana, Forente stater, 46168
        • Rekruttering
        • Sitryx Clinical Site
    • Ohio
      • Boardman, Ohio, Forente stater, 44512
        • Rekruttering
        • Sitryx Clinical Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forente stater, 19103
        • Rekruttering
        • Sitryx Clinical Site
    • Utah
      • Bountiful, Utah, Forente stater, 84010
        • Rekruttering
        • Sitryx Clinical Site
  • Irland
      • Dublin, Irland, D08 NHY1
        • Rekruttering
        • Sitryx Clinical Site
  • Storbritannia
      • Manchester, Storbritannia, M23 9QZ
        • Rekruttering
        • Sitryx Clinical Site
      • Merthyr Tydfil, Storbritannia, CF48 4DR
        • Rekruttering
        • Sitryx Clinical Site
  • Tyskland
      • Berlin, Tyskland, 10117
        • Rekruttering
        • Sitryx Clinical Site
      • Frankfurt, Tyskland, 60596
        • Rekruttering
        • Sitryx Clinical Site
      • Freiburg im Breisgau, Tyskland, 79106
        • Aktiv, ikke rekrutterende
        • Sitryx Clinical Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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).
Legemiddel: SYX-5219 Oral Capsule
Oral Capsule to be administered at each specific dose level within each cohort
Eksperimentell: Part 2 Multiple Ascending Dose (MAD)
Multiple doses of SYX-5219 (active or matching placebo) administered once or twice daily for all cohorts.
Legemiddel: SYX-5219 Oral Capsule
Oral Capsule to be administered at each specific dose level within each cohort
Eksperimentell: Part 3 AD Participants Multiple Doses
Multiple doses of SYX-5219 (active or matching placebo) administered twice daily for multiple dose administration
Legemiddel: SYX-5219 Oral Capsule
Oral Capsule to be administered at each specific dose level within each cohort

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The Proportion of Participants With Treatment-Emergent Adverse Events
Tidsramme: 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.
The number of participants who reported a treatment-emergent adverse event (TEAE) will be summarised.
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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Concentrations of SYX5219 in Plasma
Tidsramme: 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.
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.
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.
Concentrations of SYX5219 in Urine
Tidsramme: 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.
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.
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.

Andre resultatmål

Resultatmål
Tidsramme
Percent change from baseline in the Eczema Area and Severity Index (EASI) - Part 3
Tidsramme: For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
Proportion of participants achieving a 50% 75% and 90% reduction of EASI (EASI50 and EASI75 and EASI90) - Part 3
Tidsramme: For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
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
Tidsramme: For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
Percent change from baseline in peak pruritus numeric rating scale (PP-NRS) - Part 3
Tidsramme: For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
Proportion of participants with ≥3-point and ≥4-point improvement in peak pruritus numeric rating scale - Part 3
Tidsramme: For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
Percent change from baseline in weekly average of the daily PP-NRS scores - Part 3
Tidsramme: For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
Percent change from baseline in weekly average of the daily sleep loss scores - Part 3
Tidsramme: For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
Change from baseline and percent change from baseline in percent atopic dermatitis covering the body surface area (BSA) involvement - Part 3
Tidsramme: For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
Change from baseline in Dermatology Life Quality Index (DLQI) - Part 3
Tidsramme: For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
Change from baseline in Patient Orientated Eczema Measure (POEM) - Part 3
Tidsramme: For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.
For Part 3: Measured at screening, Day 1, Day 8, Day 15, Day 29, Day 43 & Day 56.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Sitryx Therapeutics Ltd

Etterforskere

  • Studieleder: Sitryx Therapeutics, Study Sponsor

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

26. februar 2025

Primær fullføring (Antatt)

30. august 2026

Studiet fullført (Antatt)

30. september 2026

Datoer for studieregistrering

Først innsendt

22. april 2026

Først innsendt som oppfylte QC-kriteriene

22. april 2026

Først lagt ut (Faktiske)

30. april 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

30. april 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

22. april 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • SYX-5219-101

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere