A Phase 1 Single Dose and Multiple Ascending Dose Study to Assess the Relative Bioavailability, Food Effect, Safety, Tolerability and Pharmacokinetics of SYT-510 in Healthy Participants

A Two-Part Study Investigating The Relative Bioavailability And The Potential Food Effect After A Single Oral Dose Administration Of A New Formulation of SYT-510, And The Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Multiple Oral Dose Administration Of SYT-510 in Healthy Subjects

Part 1 aims to investigate the relative bioavailability of a new formulation and to assess potential food effects following oral administration of SYT-510. Part 1 will then guide dosing in Part 2, a multiple dose study which aims to assess safety, tolerability and pharmacokinetic of multiple SYT-510 administrations.

Inclusion Criteria:

• Males or females of non-childbearing potential (WOCBP) aged 18 to 65 years old (inclusive) at the date of signing the informed consent form (ICF).
• Normal ECG, showing no clinically relevant deviations, as judged by the investigator.
• Body mass index (BMI) between 18 and 30 kg/m2, inclusive, at Screening and Admission (e.g Day -1 or Day -2) and a minimum weight of 50kg.

Exclusion Criteria:

• Current or recurrent disease that as judged by the Investigator may interfere with the execution of the conduct of the study.
• Laboratory parameters outside of the laboratory normal range.
• Positive test results for alcohol or drugs of abuse.
• Treatment with an investigational drug within 90 days preceding the first dose of trial medication.
• Known or suspected intolerance or hypersensitivity to the investigational product, any closely related compound, or any of the stated ingredients.
• History of significant allergic reactions (anaphylaxis, angioedema) to any product (food, pharmaceutical, etc).
• Current smokers and those who have smoked within the last 6 months.