Study identifier:D7480C00001
ClinicalTrials.gov identifier:NCT06749457
EudraCT identifier:N/A
CTIS identifier:N/A
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
Staphylococcus aureus
Phase 1/2
Yes
AZD7760
All
231
Interventional
18 Years - 55 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Prevention
Verified 01 Jan 2025 by AstraZeneca
AstraZeneca
PAREXEL
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Phase I: Cohort 1 (AZD7760 Dose A and Placebo) Participants will receive a single dose of AZD7760 Dose A or matching placebo intravenously on Day 1. | Drug: AZD7760 Participants will receive AZD7760 as a single intravenous infusion. Other: Placebo Participants will be administered placebo through intravenous infusion. |
Experimental: Phase I: Cohort 2 (AZD7760 Dose B and Placebo) Participants will receive a single dose of AZD7760 Dose B or matching placebo intravenously on Day 1. | Drug: AZD7760 Participants will receive AZD7760 as a single intravenous infusion. Other: Placebo Participants will be administered placebo through intravenous infusion. |
Experimental: Phase I: Cohort 3 (AZD7760 Dose C and Placebo) Participants will receive a single dose of AZD7760 Dose C or matching placebo intravenously on Day 1. | Drug: AZD7760 Participants will receive AZD7760 as a single intravenous infusion. Other: Placebo Participants will be administered placebo through intravenous infusion. |
Experimental: Phase IIa: Study Group 1 (AZD7760 Dose D and Placebo) Participants will receive Dose D AZD7760 on Day 1 and placebo on Day 91. | Drug: AZD7760 Participants will receive AZD7760 as a single intravenous infusion. Other: Placebo Participants will be administered placebo through intravenous infusion. |
Experimental: Phase IIa: Study Group 2 (AZD7760 Dose E) Participants will receive Dose E AZD7760 on Day 1 and Day 91. | Drug: AZD7760 Participants will receive AZD7760 as a single intravenous infusion. |
Placebo Comparator: Phase IIa: Study Group 3 (Placebo) Participants will receive placebo on Day 1 and on Day 91. | Other: Placebo Participants will be administered placebo through intravenous infusion. |