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).
Sitryx Therapeutics Ltd
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.
Description
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 eff…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- 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;…
Interventions
- DrugSYX-5219 Oral Capsule
Oral Capsule to be administered at each specific dose level within each cohort
Locations (14)
- Sitryx Clinical SiteArkansas City, Arkansas
- Sitryx Clinical SiteFremont, California
- Sitryx Clinical SitePlainfield, Indiana
- Sitryx Clinical SiteBoardman, Ohio
- Sitryx Clinical SitePhiladelphia, Pennsylvania
- Sitryx Clinical SiteBountiful, Utah