Study of AZD7760 Safety and How It Moves Through the Body in Healthy Adults and Adults With End-stage Kidney Disease on Hemodialysis Using a Central Venous Catheter

What this Trial Is About

Researchers are evaluating the safety and how the body processes AZD7760 in two groups healthy adults and adults with end-stage kidney disease who are on hemodialysis using a central venous catheter. This study includes a Phase I for healthy participants and a Phase IIa for those with kidney disease, to better understand the effects and safety of AZD7760 given intravenously. In Phase I, participants are randomly assigned to receive one of three doses of AZD7760 or a placebo as a single intravenous infusion. The study includes a 28-day screening period, a 3-day dosing period with a single infusion on the first day, and a 12-month follow-up after treatment. In Phase IIa, participants receive two intravenous infusions of either AZD7760 or placebo three months apart, with a similar 28-day screening and a 12-month follow-up after the last dose. Participants will be monitored through the study with assessments including safety evaluations for adverse events and blood tests to measure drug levels and immune responses. Researchers will track side effects, drug concentration peaks, and how long the drug stays in the body. The total involvement can last up to over a year, including screening, dosing, and follow-up periods to ensure thorough safety and pharmacokinetic monitoring.

A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)