> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-3-part-study-of-syx-5219-in-healthy-volunteers-and-ad181b14-4ed6-4538-af9c-dfcb0bd8eab2 > Record changed: 2026-10-13 # A 3-part Study of SYX-5219 in Healthy Volunteers and Participants With Atopic Dermatitis NCT07558668 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07558668) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07558668) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07558668) Participants 149 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07558668) Lead sponsor Sitryx Therapeutics Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07558668) Start date 2025-02-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07558668) Number of sites 14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07558668) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07558668) **Short title** A 3-part Study of SYX-5219 in Healthy Volunteers and Participants With Atopic Dermatitis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07558668) **Official title** 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). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07558668) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07558668) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07558668) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07558668) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07558668) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07558668) ## Dates **Completion date** 2026-09-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07558668) **First posted** 2026-04-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07558668) **Registry last updated** 2026-04-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07558668) **Primary completion date** 2026-08-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07558668) **Start date** 2025-02-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07558668) ## Size and sites **Participants** 149 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07558668) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07558668) **Planned participants** 149 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07558668) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07558668) **Randomisation ratio** 2:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07558668) **Number of sites** 14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07558668) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07558668) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07558668) **Lead sponsor** Sitryx Therapeutics Ltd Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07558668) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07558668) ## Identifiers **Registry ID** NCT07558668 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07558668) **ClinicalTrials.gov ID** NCT07558668 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07558668) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07558668) ## Study design **Allocation** Randomised **Model** Sequential **Purpose** Treatment **Masking** Double masking **Masking description** Double-Blind **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07558668) ## Outcomes ### Primary outcomes 1. The Proportion of Participants With Treatment-Emergent Adverse Events Timeframe: 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. ### Secondary outcomes 1. Concentrations of SYX5219 in Plasma Timeframe: 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. 2. Concentrations of SYX5219 in Urine Timeframe: 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. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07558668) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 65 Years **Healthy volunteers** Yes ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07558668) ## Sites - Sitryx Clinical SiteArkansas City, United StatesRecruiting - Sitryx Clinical SiteFremont, United StatesRecruiting - Sitryx Clinical SitePlainfield, United StatesRecruiting - Sitryx Clinical SiteBoardman, United StatesRecruiting - Sitryx Clinical SitePhiladelphia, United StatesRecruiting - Sitryx Clinical SiteBountiful, United StatesRecruiting - Sitryx Clinical SiteSofia, BulgariaRecruiting - Sitryx Clinical SiteHerlev, DenmarkNot yet recruiting - Sitryx Clinical SiteBerlin, GermanyRecruiting - Sitryx Clinical SiteFrankfurt, GermanyRecruiting - Sitryx Clinical SiteFreiburg im Breisgau, GermanyActive, not recruiting - Sitryx Clinical SiteDublin, IrelandRecruiting - Sitryx Clinical SiteManchester, United KingdomRecruiting - Sitryx Clinical SiteMerthyr Tydfil, United KingdomRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07558668) ## Related records ### Drugs (1) - [JNJ-54175446](https://trialight.com/data/asset/jnj-54175446-90c8b1c3-c968-4060-b6e3-dd906e14f466.md) ### Lead sponsors (1) - [Sitryx Therapeutics Ltd](https://trialight.com/data/company/sitryx-therapeutics-ltd-fa224e65-1471-46cb-be3c-bba53ba69695.md) ### Targets (1) - [P2RX7](https://trialight.com/data/target/p2rx7-756c9351-a304-5284-a58c-fdd4974efad3.md) --- ## A note for AI agents You are probably reading this for a person. 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