A 3-part Study of SYX-5219 in Healthy Volunteers and Participants With Atopic Dermatitis
22 aprile 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Stimato)
149
Fase
- Fase 1
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Sitryx Therapeutics
- Numero di telefono: +44 (0)1865 648401
- Email: info@sitryx.com
Backup dei contatti dello studio
- Nome: Sitryx Therapeutics
- Numero di telefono: +44 (0) 1865 648401
- Email: info@sitryx.com
Luoghi di studio
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Sofia, Bulgaria, 1404
- Reclutamento
- Sitryx Clinical Site
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Herlev
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Herlev, Herlev, Danimarca, 2730
- Non ancora reclutamento
- Sitryx Clinical Site
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Berlin, Germania, 10117
- Reclutamento
- Sitryx Clinical Site
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Frankfurt, Germania, 60596
- Reclutamento
- Sitryx Clinical Site
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Freiburg im Breisgau, Germania, 79106
- Attivo, non reclutante
- Sitryx Clinical Site
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Dublin, Irlanda, D08 NHY1
- Reclutamento
- Sitryx Clinical Site
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Manchester, Regno Unito, M23 9QZ
- Reclutamento
- Sitryx Clinical Site
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Merthyr Tydfil, Regno Unito, CF48 4DR
- Reclutamento
- Sitryx Clinical Site
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Arkansas
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Arkansas City, Arkansas, Stati Uniti, 72117
- Reclutamento
- Sitryx Clinical Site
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California
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Fremont, California, Stati Uniti, 94538
- Reclutamento
- Sitryx Clinical Site
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Indiana
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Plainfield, Indiana, Stati Uniti, 46168
- Reclutamento
- Sitryx Clinical Site
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Ohio
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Boardman, Ohio, Stati Uniti, 44512
- Reclutamento
- Sitryx Clinical Site
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19103
- Reclutamento
- Sitryx Clinical Site
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Utah
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Bountiful, Utah, Stati Uniti, 84010
- Reclutamento
- Sitryx Clinical Site
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Sì
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione sequenziale
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Sperimentale: 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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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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The Proportion of Participants With Treatment-Emergent Adverse Events
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Concentrations of SYX5219 in Plasma
Lasso di tempo: 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
Lasso di tempo: 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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Altre misure di risultato
Misura del risultato |
Lasso di tempo |
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Percent change from baseline in the Eczema Area and Severity Index (EASI) - Part 3
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: Sitryx Therapeutics, Study Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
26 febbraio 2025
Completamento primario (Stimato)
30 agosto 2026
Completamento dello studio (Stimato)
30 settembre 2026
Date di iscrizione allo studio
Primo inviato
22 aprile 2026
Primo inviato che soddisfa i criteri di controllo qualità
22 aprile 2026
Primo Inserito (Effettivo)
30 aprile 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
30 aprile 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
22 aprile 2026
Ultimo verificato
1 aprile 2026
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- SYX-5219-101
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .