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

2026年4月22日 更新者：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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

149

阶段

  • 阶段1

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Sitryx Therapeutics
  • 电话号码：+44 (0)1865 648401
  • 邮箱：info@sitryx.com

研究联系人备份

  • 姓名：Sitryx Therapeutics
  • 电话号码：+44 (0) 1865 648401
  • 邮箱：info@sitryx.com

学习地点

  • 丹麦
    • Herlev
      • Herlev、Herlev、丹麦、2730
        • 尚未招聘
        • Sitryx Clinical Site
  • 保加利亚
      • Sofia、保加利亚、1404
        • 招聘中
        • Sitryx Clinical Site
  • 德国
      • Berlin、德国、10117
        • 招聘中
        • Sitryx Clinical Site
      • Frankfurt、德国、60596
        • 招聘中
        • Sitryx Clinical Site
      • Freiburg im Breisgau、德国、79106
        • 主动，不招人
        • Sitryx Clinical Site
  • 爱尔兰
      • Dublin、爱尔兰、D08 NHY1
        • 招聘中
        • Sitryx Clinical Site
  • 美国
    • Arkansas
      • Arkansas City、Arkansas、美国、72117
        • 招聘中
        • Sitryx Clinical Site
    • California
      • Fremont、California、美国、94538
        • 招聘中
        • Sitryx Clinical Site
    • Indiana
      • Plainfield、Indiana、美国、46168
        • 招聘中
        • Sitryx Clinical Site
    • Ohio
      • Boardman、Ohio、美国、44512
        • 招聘中
        • Sitryx Clinical Site
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19103
        • 招聘中
        • Sitryx Clinical Site
    • Utah
      • Bountiful、Utah、美国、84010
        • 招聘中
        • Sitryx Clinical Site
  • 英国
      • Manchester、英国、M23 9QZ
        • 招聘中
        • Sitryx Clinical Site
      • Merthyr Tydfil、英国、CF48 4DR
        • 招聘中
        • Sitryx Clinical Site

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：顺序分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：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).
药品：SYX-5219 Oral Capsule
Oral Capsule to be administered at each specific dose level within each cohort
实验性的：Part 2 Multiple Ascending Dose (MAD)
Multiple doses of SYX-5219 (active or matching placebo) administered once or twice daily for all cohorts.
药品：SYX-5219 Oral Capsule
Oral Capsule to be administered at each specific dose level within each cohort
实验性的：Part 3 AD Participants Multiple Doses
Multiple doses of SYX-5219 (active or matching placebo) administered twice daily for multiple dose administration
药品：SYX-5219 Oral Capsule
Oral Capsule to be administered at each specific dose level within each cohort

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
The Proportion of Participants With Treatment-Emergent Adverse Events
大体时间：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.

次要结果测量

结果测量
措施说明
大体时间
Concentrations of SYX5219 in Plasma
大体时间：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
大体时间：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.

其他结果措施

结果测量
大体时间
Percent change from baseline in the Eczema Area and Severity Index (EASI) - Part 3
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Sitryx Therapeutics Ltd

调查人员

  • 研究主任：Sitryx Therapeutics、Study Sponsor

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年2月26日

初级完成 (估计的)

2026年8月30日

研究完成 (估计的)

2026年9月30日

研究注册日期

首次提交

2026年4月22日

首先提交符合 QC 标准的

2026年4月22日

首次发布 (实际的)

2026年4月30日

研究记录更新

最后更新发布 (实际的)

2026年4月30日

上次提交的符合 QC 标准的更新

2026年4月22日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • SYX-5219-101

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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