A 3-part Study of SYX-5219 in Healthy Volunteers and Participants With Atopic Dermatitis
22 april 2026 uppdaterad 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
149
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Sitryx Therapeutics
- Telefonnummer: +44 (0)1865 648401
- E-post: info@sitryx.com
Studera Kontakt Backup
- Namn: Sitryx Therapeutics
- Telefonnummer: +44 (0) 1865 648401
- E-post: info@sitryx.com
Studieorter
-
-
-
Sofia, Bulgarien, 1404
- Rekrytering
- Sitryx Clinical Site
-
-
-
-
Herlev
-
Herlev, Herlev, Danmark, 2730
- Har inte rekryterat ännu
- Sitryx Clinical Site
-
-
-
-
Arkansas
-
Arkansas City, Arkansas, Förenta staterna, 72117
- Rekrytering
- Sitryx Clinical Site
-
-
California
-
Fremont, California, Förenta staterna, 94538
- Rekrytering
- Sitryx Clinical Site
-
-
Indiana
-
Plainfield, Indiana, Förenta staterna, 46168
- Rekrytering
- Sitryx Clinical Site
-
-
Ohio
-
Boardman, Ohio, Förenta staterna, 44512
- Rekrytering
- Sitryx Clinical Site
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Förenta staterna, 19103
- Rekrytering
- Sitryx Clinical Site
-
-
Utah
-
Bountiful, Utah, Förenta staterna, 84010
- Rekrytering
- Sitryx Clinical Site
-
-
-
-
-
Dublin, Irland, D08 NHY1
- Rekrytering
- Sitryx Clinical Site
-
-
-
-
-
Manchester, Storbritannien, M23 9QZ
- Rekrytering
- Sitryx Clinical Site
-
Merthyr Tydfil, Storbritannien, CF48 4DR
- Rekrytering
- Sitryx Clinical Site
-
-
-
-
-
Berlin, Tyskland, 10117
- Rekrytering
- Sitryx Clinical Site
-
Frankfurt, Tyskland, 60596
- Rekrytering
- Sitryx Clinical Site
-
Freiburg im Breisgau, Tyskland, 79106
- Aktiv, inte rekryterande
- Sitryx Clinical Site
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Sekventiell tilldelning
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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).
|
Oral Capsule to be administered at each specific dose level within each cohort
|
|
Experimentell: Part 2 Multiple Ascending Dose (MAD)
Multiple doses of SYX-5219 (active or matching placebo) administered once or twice daily for all cohorts.
|
Oral Capsule to be administered at each specific dose level within each cohort
|
|
Experimentell: Part 3 AD Participants Multiple Doses
Multiple doses of SYX-5219 (active or matching placebo) administered twice daily for multiple dose administration
|
Oral Capsule to be administered at each specific dose level within each cohort
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The Proportion of Participants With Treatment-Emergent Adverse Events
Tidsram: 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.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Concentrations of SYX5219 in Plasma
Tidsram: 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
Tidsram: 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.
|
Andra resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Percent change from baseline in the Eczema Area and Severity Index (EASI) - Part 3
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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.
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Sitryx Therapeutics, Study Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
26 februari 2025
Primärt slutförande (Beräknad)
30 augusti 2026
Avslutad studie (Beräknad)
30 september 2026
Studieregistreringsdatum
Först inskickad
22 april 2026
Först inskickad som uppfyllde QC-kriterierna
22 april 2026
Första postat (Faktisk)
30 april 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
30 april 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
22 april 2026
Senast verifierad
1 april 2026
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- SYX-5219-101
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .