Actively Recruiting
A Phase I/IIa Study to Evaluate Safety and Pharmacokinetics of AZD7760 in Healthy Adults and Adults With End-stage Kidney Disease on Hemodialysis
Led by AstraZeneca · Updated on 2026-05-01
231
Participants Needed
42
Research Sites
40 weeks
Total Duration
On this page
Sponsors
A
AstraZeneca
Lead Sponsor
P
Parexel
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and how the body processes AZD7760 when given through an intravenous infusion. This study includes healthy adults in Phase I and adults with end-stage kidney disease who receive hemodialysis through a central venous catheter in Phase IIa. The purpose is to understand the safety and pharmacokinetics of AZD7760 in these two groups. In Phase I, participants will be randomly assigned to receive one of three doses of AZD7760 or a placebo as a single intravenous infusion on Day 1. This phase includes a 28-day screening period, a 3-day dosing period with one infusion, and a 12-month follow-up after treatment. In Phase IIa, participants with kidney disease will be randomly assigned to receive AZD7760 or placebo as two intravenous infusions 3 months apart, on Day 1 and Day 91, following a 28-day screening and a 12-month follow-up after the last dose. Participants will be monitored through regular assessments during screening, dosing, and follow-up periods. Researchers will track adverse events and measure drug levels in the blood over time. Safety evaluations include checking for any serious or special interest adverse events. The study lasts up to 12 months after the last drug administration, during which participants undergo physical exams, lab tests, and other monitoring to understand the effects and safety of AZD7760.
CONDITIONS
Brief Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Phase I: Adults aged 18 to 55 years at consent
- Phase I: Body weight between 45 and 110 kg and BMI between 18.0 and 30.0 kg/m2
- Phase I: Healthy with no significant diseases or medications as judged by the investigator
- Phase IIa: Adults aged 18 years or older at consent
- Phase IIa: Diagnosed with end-stage kidney disease
- Phase IIa: Require hemodialysis through a tunneled central venous catheter
- Phase IIa: Receiving hemodialysis for at least 90 days before randomization
- Phase IIa: At least 3 dialysis sessions with current dialyzer
- Phase IIa: Adequate hemodialysis based on Kt/V measurement > 1.2 within last 30 days
- Phase IIa: No new medications added in last 2 weeks before dosing
- Phase IIa: Not taking long-term systemic antibiotics active against Staphylococcus aureus
You will not qualify if you...
- Phase I: Known allergy to study intervention components
- Phase I: Past severe allergic or infusion reactions to monoclonal antibodies
- Phase I: Significant bleeding disorders or history of bleeding after injections
- Phase I: Elevated liver enzymes (AST or ALT) above 1.5 times normal
- Phase I: Estimated glomerular filtration rate below 90 mL/min/1.73 m2
- Phase I: Low hemoglobin or platelet counts at screening
- Phase I: Abnormal white blood cell counts outside normal ranges unless justified
- Phase I: History of cancer except treated non-melanoma skin or cervical cancer within 5 years
- Phase I: Clinically significant lab abnormalities or ECG changes
- Phase I: Recent acute illness or fever above 38°C before dosing
- Phase I: Known or suspected immune deficiency or recent immunosuppressive therapy
- Phase I: Conditions increasing drug clearance like severe enteropathies
- Phase I: Excessive blood drawn in last 2 months
- Phase I: No suitable veins for blood sampling or drug administration
- Phase I: Any other condition compromising safety or study evaluation
- Phase IIa: Known allergy to study intervention components
- Phase IIa: Allergic diseases likely worsened by study drug components
- Phase IIa: Past severe allergic or infusion reactions to monoclonal antibodies
- Phase IIa: Low hemoglobin (<9 g/dL) or low albumin (<3 g/dL) due to acute conditions
- Phase IIa: Recent serious cardiovascular or thrombotic events within 90 days
- Phase IIa: Known Staphylococcus aureus infection within 90 days
- Phase IIa: Recent acute infections within 21 days before infusion
- Phase IIa: Current cancer chemotherapy
- Phase IIa: Scheduled living donor kidney transplant
- Phase IIa: Plans to switch to peritoneal dialysis or vascular access changes within 181 days
- Phase IIa: Presence or planned arteriovenous graft or fistula with anticipated use within 90 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 28 days
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 days for Phase I; approximately 3 months for Phase IIa
Participants receive one or two intravenous infusions of AZD7760 or placebo depending on the study phase and assigned dose.
1 infusion visit on Day 1 for Phase I; 2 infusion visits on Day 1 and Day 91 for Phase IIa
Duration - Up to 12 months after last dosing
Participants are monitored for safety and pharmacokinetics after receiving the study intervention.
Regular follow-up visits over 12 months
Trial Site Locations
Total: 42 locations
1
Research Site
Huntsville, Alabama, United States, 35805
Actively Recruiting
2
Research Site
Chula Vista, California, United States, 91910
Withdrawn
3
Research Site
Chula Vista, California, United States, 91910
Actively Recruiting
4
Research Site
Glendale, California, United States, 91206
Actively Recruiting
5
Research Site
Granada Hills, California, United States, 91344
Actively Recruiting
6
Research Site
Los Angeles, California, United States, 90027
Actively Recruiting
7
Research Site
Northridge, California, United States, 91324
Actively Recruiting
8
Research Site
Northridge, California, United States, 91325
Actively Recruiting
9
Research Site
Oxnard, California, United States, 93036
Actively Recruiting
10
Research Site
Riverside, California, United States, 92503
Actively Recruiting
11
Research Site
San Dimas, California, United States, 91773
Actively Recruiting
12
Research Site
Tarzana, California, United States, 91356
Actively Recruiting
13
Research Site
Valencia, California, United States, 91355
Actively Recruiting
14
Research Site
Victorville, California, United States, 92392
Actively Recruiting
15
Research Site
Englewood, Colorado, United States, 80110
Actively Recruiting
16
Research Site
Bradenton, Florida, United States, 34209
Actively Recruiting
17
Research Site
Coral Springs, Florida, United States, 33071
Actively Recruiting
18
Research Site
Hollywood, Florida, United States, 33024
Actively Recruiting
19
Research Site
Orlando, Florida, United States, 32806
Actively Recruiting
20
Research Site
Tampa, Florida, United States, 33603
Actively Recruiting
21
Research Site
Lawrenceville, Georgia, United States, 30046
Not Yet Recruiting
22
Research Site
Chicago, Illinois, United States, 60640
Actively Recruiting
23
Research Site
Chicago, Illinois, United States, 60643
Actively Recruiting
24
Research Site
Iowa City, Iowa, United States, 52242
Actively Recruiting
25
Research Site
Baltimore, Maryland, United States, 21225
Actively Recruiting
26
Research Site
Detroit, Michigan, United States, 48202
Actively Recruiting
27
Research Site
Pontiac, Michigan, United States, 48341
Actively Recruiting
28
Research Site
Tupelo, Mississippi, United States, 38801
Actively Recruiting
29
Research Site
Kansas City, Missouri, United States, 64111
Actively Recruiting
30
Research Site
Lincoln, Nebraska, United States, 68510
Actively Recruiting
31
Research Site
Jersey City, New Jersey, United States, 07305
Actively Recruiting
32
Research Site
Albuquerque, New Mexico, United States, 87109
Actively Recruiting
33
Research Site
Ridgewood, New York, United States, 11385
Actively Recruiting
34
Research Site
Kinston, North Carolina, United States, 28504
Withdrawn
35
Research Site
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
36
Research Site
Bethlehem, Pennsylvania, United States, 18017
Actively Recruiting
37
Research Site
Knoxville, Tennessee, United States, 37923
Withdrawn
38
Research Site
Beaumont, Texas, United States, 77706
Actively Recruiting
39
Research Site
Dallas, Texas, United States, 75246
Actively Recruiting
40
Research Site
Houston, Texas, United States, 77074
Actively Recruiting
41
Research Site
McAllen, Texas, United States, 78503
Actively Recruiting
42
Research Site
San Antonio, Texas, United States, 78215
Withdrawn
Research Team
A
AstraZeneca Clinical Study Information Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
7
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