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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).
In the Phase I portion of the study, participants will be randomized to receive one of 3 dosages of AZD7760 or placebo as a single intravenous infusion. Study details include: * A 28-day Screening Period. * A Dosing Period of 3 days in which a single intravenous infusion will be given on Day 1. * A Follow-up Period of 12 months from the time of administration of the study intervention. In the Phase IIa portion of the study, participants will be randomized to receive either AZD7760 or placebo as 2 intravenous infusions given 3 months apart. Study details include: * A 28-day Screening Period. * A Dosing Period in which 2 intravenous infusions will be given 3 months apart (Day 1 and Day 91). * A Follow-up Period of 12 months after the last administration of the study intervention on Day 91.
Age
18 - 55 years
Sex
ALL
Healthy Volunteers
Yes
Research Site
Huntsville, Alabama, United States
Research Site
Chula Vista, California, United States
Research Site
Chula Vista, California, United States
Research Site
Glendale, California, United States
Research Site
Granada Hills, California, United States
Research Site
Los Angeles, California, United States
Research Site
Northridge, California, United States
Research Site
Northridge, California, United States
Research Site
Oxnard, California, United States
Research Site
Riverside, California, United States
Start Date
December 30, 2024
Primary Completion Date
October 9, 2026
Completion Date
July 6, 2027
Last Updated
March 9, 2026
231
ESTIMATED participants
AZD7760
DRUG
Placebo
OTHER
AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479information.center@astrazeneca.comLead Sponsor
AstraZeneca
Collaborators
NCT06650501
NCT05632315
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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