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

Launched by SYNENDOS THERAPEUTICS AG · Oct 31, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new medication called SYT-510 to see how well it is absorbed in the body, how food might affect its absorption, and how safe it is for healthy adults. The study has two parts: the first part will give a single dose of SYT-510 to understand how the body processes it, and the second part will involve giving multiple doses to assess its safety and how well people tolerate it over time.

To participate in this trial, you need to be between 18 and 65 years old, in good health, and meet certain criteria like having a healthy body weight and normal heart function. Participants can expect to undergo some tests and monitoring during the study to ensure their safety. It's important to note that individuals with certain health issues, allergies, or those who smoke may not be eligible. This study is currently recruiting participants, so if you or someone you know is interested, it could be an opportunity to contribute to research on this new medication.

Gender

ALL

Eligibility criteria

• 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.