Phase 1 Randomized Study of S-1117 Given by Injection in Healthy Adults Ages 18 to 65

What this Trial Is About

Researchers are conducting a first-in-human, phase 1 clinical trial to study S-1117, a drug being tested in healthy adult volunteers. The study aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of S-1117. It is a randomized, placebo-controlled, double-blind trial sponsored by Seismic Therapeutic AU Pty Ltd, designed to collect important data on how the drug behaves in the human body. The trial is divided into two parts Part 1 involves single ascending doses SAD of S-1117, and Part 2 involves multiple ascending doses MAD. Both S-1117 and placebo are administered either subcutaneously or intravenously. Participants will receive varying doses to help assess how the drug is processed and tolerated over time. Participants will be monitored closely with assessments over approximately two months, including tracking any treatment-related adverse events. Researchers will measure drug levels in the blood, including maximum concentration, time to reach peak levels, elimination half-life, clearance, volume of distribution, and bioavailability. Immunologic responses, such as changes in immunoglobulin G and the development of antidrug antibodies, will also be evaluated. The study includes regular safety monitoring and follow-up to ensure participant well-being throughout the trial.

A Phase 1 Study of S-1117