Phase 1 Evaluation of IV CTX-187 Safety and Effects in Healthy Adults and Adults with Bacterial Lung Infection

What this Trial Is About

Researchers are evaluating the safety and tolerability of CTX-187, an investigational drug given through intravenous IV infusion, in healthy adults and adults with bacterial lung infections, specifically bronchiectasis patients chronically infected with Pseudomonas aeruginosa. This Phase 1 trial aims to understand how the drug behaves in the body and its safety profile in these two groups. The study involves several groups healthy participants receive either a single dose or multiple doses of CTX-187 or placebo via IV infusion. The dosing in healthy participants is either a single ascending dose or multiple ascending doses given twice daily for 7 days. Participants with bacterial infections receive multiple ascending doses of CTX-187 or placebo twice daily for 6 days, with additional single doses on the first and eighth day. Participants will be closely monitored through the study for treatment-emergent adverse events up to 28 days after dosing. Researchers will collect blood samples to measure how CTX-187 is processed in the body, including levels over time and the presence of antibodies against the drug. The study includes regular visits for dosing and assessments, and participants will be observed until the study end date in 2027.

First in Human Trial of CTX-187 in Healthy Volunteers and Chronically Infected Patients