A Phase I/IIa Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetics of AZD7760 in Healthy Participants and in Patients With End-stage Kidney Disease Receiving Hemodialysis Through a Central Venous Catheter
The purpose of this study is to evaluate the safety and pharmacokinetics (PK) of AZD7760 when given as an intravenous infusion to healthy participants (Phase I) or participants with end-stage kidney disease receiving hemodialysis through a central venous catheter (Phase IIa).
∙ Phase I:
• Participant must be 18 to 55 years of age (inclusive), at the time of signing the informed consent.
• Body weight ≥ 45 kilograms (kg) and ≤ 110 kg and Body Mass Index (BMI) within the range ≥ 18.0 to ≤ 30.0 kilograms per square meter (kg/m2) (inclusive) at screening.
• Healthy participants with no clinically significant concomitant diseases or medications (except for those specifically permitted by the protocol) according to medical history, physical examination, screening safety laboratory tests, and screening parameters, as perthe judgement of the investigator.
∙ Phase IIa:
• Participant must be ≥ 18 years of age at the time of signing the informed consent.
• Participants who meet all of the following disease status requirements:
‣ Diagnosed with End-stage kidney disease (ESKD).
⁃ Requiring hemodialysis through a tunneled central venous catheter as the primary vascular access for hemodialysis.
⁃ Receiving hemodialysis for treatment of ESKD for at least 90 days before randomization.
⁃ At least 3 previous dialysis sessions using current dialyzer.
⁃ Receiving adequate hemodialysis based on a single-pool Kt/V measurement \> 1.2 within the last 30 days.
⁃ No new medications have been added to the participant's regimen in the last 2 weeks prior to dosing. 'New medication' is defined as any medication that has not been prescribed or used by the participant previously (including formulation changes). Medication previously prescribed or used by the participant with dose adjustments is allowed and not considered as new medication for the purpose of this study.
⁃ Not taking long-term systemic antibiotics with activity against S aureus.