Phase 1 Study of Single-Dose SPY002-072 Safety and Pharmacokinetics in Healthy Adults Aged 18 to 60

What this Trial Is About

Researchers are conducting a Phase 1 clinical trial to study SPY002-072, focusing on its safety, tolerability, and how the body processes this drug in healthy adult volunteers. This first-in-human, randomized, double-blind, placebo-controlled study aims to gather important early data on SPY002-072 by comparing it to a placebo. The study is led by Spyre Therapeutics, Inc. and involves healthy men and women aged 18 to 60 years. Participants will receive a single dose of SPY002-072 or a placebo in a dose escalation format, meaning different groups will receive increasing doses to evaluate safety and drug behavior at various levels. The study design includes randomized assignment to either the drug or placebo group, with neither participants nor researchers knowing which treatment any individual receives, to ensure unbiased results. During the study, participants will attend visits at the clinical research unit and remain confined there for a period to allow close monitoring. They will undergo various tests to track any treatment-related side effects, as well as measurements of drug concentration over time, including peak levels and half-life. Follow-up visits will continue for up to 40 weeks to assess safety and drug behavior. Participants will be carefully observed for any adverse events throughout the study period.

A Study of SPY002-072 in Healthy Volunteers