Phase I Study of AZD7760 IV Infusion to Assess Safety and Pharmacokinetics in Healthy Japanese Adults Aged 18 to 55

What this Trial Is About

Researchers are evaluating the safety and pharmacokinetics PK of AZD7760, a combination of two monoclonal antibodies, in healthy Japanese adults. This phase I, randomized, double-blind, placebo-controlled study focuses on assessing how the body processes AZD7760 and monitors safety in adults aged 18 to 55 years without significant health issues. The trial aims to better understand the effects of this investigational drug for potential prevention of Staphylococcus aureus bloodstream infection. Participants will receive a single intravenous IV infusion of one of two doses of AZD7760 or a matching placebo on Day 1. The study consists of a screening period lasting up to 28 days, followed by the dosing period of 3 days during which the infusion occurs on the first day. After dosing, participants will be followed for 12 months to monitor safety and drug levels in the body. During the study, participants will undergo various safety assessments including monitoring for adverse events, medically attended adverse events, and special interest events for up to 361 days. Blood samples will be collected to measure drug concentration and immune response. Participants will be evaluated regularly through laboratory tests, physical exams, and questionnaires to ensure safety and gather pharmacokinetic data throughout the follow-up period.

A Study to Evaluate the Safety and Pharmacokinetics of AZD7760 in Healthy Japanese Adults