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

22. April 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

149

Phase

  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

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

Studieren Sie die Kontaktsicherung

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

Studienorte

  • Bulgarien
      • Sofia, Bulgarien, 1404
        • Rekrutierung
        • Sitryx Clinical Site
  • Deutschland
      • Berlin, Deutschland, 10117
        • Rekrutierung
        • Sitryx Clinical Site
      • Frankfurt, Deutschland, 60596
        • Rekrutierung
        • Sitryx Clinical Site
      • Freiburg im Breisgau, Deutschland, 79106
        • Aktiv, nicht rekrutierend
        • Sitryx Clinical Site
  • Dänemark
    • Herlev
      • Herlev, Herlev, Dänemark, 2730
        • Noch keine Rekrutierung
        • Sitryx Clinical Site
  • Irland
      • Dublin, Irland, D08 NHY1
        • Rekrutierung
        • Sitryx Clinical Site
  • Vereinigte Staaten
    • Arkansas
      • Arkansas City, Arkansas, Vereinigte Staaten, 72117
        • Rekrutierung
        • Sitryx Clinical Site
    • California
      • Fremont, California, Vereinigte Staaten, 94538
        • Rekrutierung
        • Sitryx Clinical Site
    • Indiana
      • Plainfield, Indiana, Vereinigte Staaten, 46168
        • Rekrutierung
        • Sitryx Clinical Site
    • Ohio
      • Boardman, Ohio, Vereinigte Staaten, 44512
        • Rekrutierung
        • Sitryx Clinical Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, Vereinigte Staaten, 19103
        • Rekrutierung
        • Sitryx Clinical Site
    • Utah
      • Bountiful, Utah, Vereinigte Staaten, 84010
        • Rekrutierung
        • Sitryx Clinical Site
  • Vereinigtes Königreich
      • Manchester, Vereinigtes Königreich, M23 9QZ
        • Rekrutierung
        • Sitryx Clinical Site
      • Merthyr Tydfil, Vereinigtes Königreich, CF48 4DR
        • Rekrutierung
        • Sitryx Clinical Site

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Sequenzielle Zuweisung
  • Maskierung: Doppelt

Waffen und Interventionen

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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
The Proportion of Participants With Treatment-Emergent Adverse Events
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Concentrations of SYX5219 in Plasma
Zeitfenster: 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
Zeitfenster: 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.

Andere Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Percent change from baseline in the Eczema Area and Severity Index (EASI) - Part 3
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Sitryx Therapeutics Ltd

Ermittler

  • Studienleiter: Sitryx Therapeutics, Study Sponsor

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

26. Februar 2025

Primärer Abschluss (Geschätzt)

30. August 2026

Studienabschluss (Geschätzt)

30. September 2026

Studienanmeldedaten

Zuerst eingereicht

22. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

22. April 2026

Zuerst gepostet (Tatsächlich)

30. April 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

30. April 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

22. April 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • SYX-5219-101

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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