A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single and Multiple Ascending Dose Trial of S-4321 in Healthy Volunteers

What this Trial Is About

Researchers are evaluating S-4321 in this first-in-human, phase 1 clinical trial to gather information on its safety, tolerability, and how the body processes and responds to it. The study involves healthy adult volunteers and aims to provide initial data on potential effects and biological activity of S-4321 compared to a placebo. This randomized, double-blind, placebo-controlled study is sponsored by Seismic Therapeutic AU Pty Ltd and includes two parts to test different dosing schedules. The trial has two parts: Part 1 where participants receive single ascending doses of S-4321 or placebo, and Part 2 where participants receive multiple ascending doses, administered either subcutaneously or intravenously. This design allows researchers to carefully monitor how the drug behaves in the body at different dose levels and over time. Both S-4321 and placebo are given under controlled conditions during these periods. Participants are closely monitored through various safety assessments and laboratory tests over about two months. The main focus is on any treatment-related adverse events. Researchers will also measure how much of the drug enters the bloodstream, how long it stays, and how it affects receptor occupancy. Additional evaluations include antibody response against the drug. Participants must be available for the entire study period and follow-up to ensure complete data collection.

A Phase 1 Study of S-4321