Phase 1 Study of SYNT-101 to Assess Safety and Effects in Healthy and Overweight Adults Aged 18 to 55

What this Trial Is About

Researchers are conducting a Phase 1 study to evaluate the safety, tolerability, and pharmacodynamics of SYNT-101, a drug being studied in healthy and overweight adults aged 18 to 55. This randomized, double-blind, placebo-controlled trial aims to understand how the drug behaves in the body and its safety profile. The study is sponsored by Syntis Bio and focuses on initial human testing to gather important information about SYNT-101. Participants will receive either SYNT-101 tablets or matching placebo tablets in single ascending doses and multiple ascending doses. The study involves carefully controlled dosing schedules to monitor how the drug is processed in the body over time. Both single and repeated doses will be tested to assess safety and drug levels in the blood. During the study, participants will undergo safety evaluations from enrollment through up to 36 days after dosing, including monitoring for adverse effects. Blood samples will be collected at multiple time points after dosing to measure drug concentration and pharmacokinetics. Volunteers will be asked to comply with all study assessments and follow the protocol throughout the trial, which includes frequent visits and monitoring by the research team.

A Study of SYNT-101 to Test Safety, Tolerability and Pharmacodynamics of SYNT-101 in Healthy and Overweight Adults