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)
Start Date
12/30/2024
Completion Date
1/7/2028
Summary
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).
Detailed Description
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.
Eligibility Criteria
Age Range: 18 years to 55 years
Interventions
AZD7760
Placebo
Conditions
Locations
Research Site
Huntsville, Alabama 35805
United States
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Chula Vista, California 91910
United States
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Chula Vista, California 91910
United States
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Glendale, California 91206
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Granada Hills, California 91344
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Los Angeles, California 90027
United States
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Northridge, California 91324
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Northridge, California 91325
United States
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Oxnard, California 93036
United States
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Riverside, California 92503
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San Dimas, California 91773
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Tarzana, California 91356
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Valencia, California 91355
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Victorville, California 92392
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Englewood, Colorado 80110
United States
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Bradenton, Florida 34209
United States
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Coral Springs, Florida 33071
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Hollywood, Florida 33024
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Orlando, Florida 32806
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Tampa, Florida 33603
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Lawrenceville, Georgia 30046
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Chicago, Illinois 60640
United States
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Chicago, Illinois 60643
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Iowa City, Iowa 52242
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Lexington, Kentucky 40503
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Baltimore, Maryland 21225
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Detroit, Michigan 48202
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Pontiac, Michigan 48341
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Tupelo, Mississippi 38801
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Kansas City, Missouri 64111
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Lincoln, Nebraska 68510
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Jersey City, New Jersey 07305
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Albuquerque, New Mexico 87109
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Ridgewood, New York 11385
United States
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Kinston, North Carolina 28504
United States
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Winston-Salem, North Carolina 27103
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Bethlehem, Pennsylvania 18017
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Knoxville, Tennessee 37923
United States
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Beaumont, Texas 77706
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Dallas, Texas 75246
United States
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Houston, Texas 77074
United States
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McAllen, Texas 78503
United States
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San Antonio, Texas 78215
United States