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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
149
段階
- フェーズ 1
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Sitryx Therapeutics
- 電話番号：+44 (0)1865 648401
- メール：info@sitryx.com
研究連絡先のバックアップ
- 名前：Sitryx Therapeutics
- 電話番号：+44 (0) 1865 648401
- メール：info@sitryx.com
研究場所
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Dublin、アイルランド、D08 NHY1
- 募集
- Sitryx Clinical Site
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Arkansas
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Arkansas City、Arkansas、アメリカ、72117
- 募集
- Sitryx Clinical Site
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California
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Fremont、California、アメリカ、94538
- 募集
- Sitryx Clinical Site
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Indiana
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Plainfield、Indiana、アメリカ、46168
- 募集
- Sitryx Clinical Site
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Ohio
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Boardman、Ohio、アメリカ、44512
- 募集
- Sitryx Clinical Site
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19103
- 募集
- Sitryx Clinical Site
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Utah
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Bountiful、Utah、アメリカ、84010
- 募集
- Sitryx Clinical Site
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Manchester、イギリス、M23 9QZ
- 募集
- Sitryx Clinical Site
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Merthyr Tydfil、イギリス、CF48 4DR
- 募集
- Sitryx Clinical Site
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Herlev
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Herlev、Herlev、デンマーク、2730
- まだ募集していません
- Sitryx Clinical Site
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Berlin、ドイツ、10117
- 募集
- Sitryx Clinical Site
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Frankfurt、ドイツ、60596
- 募集
- Sitryx Clinical Site
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Freiburg im Breisgau、ドイツ、79106
- 積極的、募集していない
- Sitryx Clinical Site
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Sofia、ブルガリア、1404
- 募集
- Sitryx Clinical Site
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：順次割り当て
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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).
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Oral Capsule to be administered at each specific dose level within each cohort
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実験的：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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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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The Proportion of Participants With Treatment-Emergent Adverse Events
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Concentrations of SYX5219 in Plasma
時間枠：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
時間枠：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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その他の成果指標
結果測定 |
時間枠 |
|---|---|
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Percent change from baseline in the Eczema Area and Severity Index (EASI) - Part 3
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディディレクター：Sitryx Therapeutics、Study Sponsor
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2025年2月26日
一次修了 (推定)
2026年8月30日
研究の完了 (推定)
2026年9月30日
試験登録日
最初に提出
2026年4月22日
QC基準を満たした最初の提出物
2026年4月22日
最初の投稿 (実際)
2026年4月30日
学習記録の更新
投稿された最後の更新 (実際)
2026年4月30日
QC基準を満たした最後の更新が送信されました
2026年4月22日
最終確認日
2026年4月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- SYX-5219-101
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
はい
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。