A Study of AZD7760 for Staphylococcus Aureus Infection
This study is testing a new medicine called AZD7760, given as a single intravenous (IV) infusion, to see how safe it is and how it moves through the body. It's for healthy adults (Phase I) and adults with end-stage kidney disease who are on hemodialysis (Phase IIa) and have a central venous catheter. The main goal is to track any side effects (adverse events) that happen. You could be eligible if you are between 18 and 55 years old, weigh between 45 and 110 kg, and have a BMI between 18.0 and 30.0. The study is currently unclear on its recruitment status.
- Study design
- This is an interventional study with two phases. In Phase I, healthy participants will be randomly assigned to receive one of three doses of AZD7760 or a placebo. In Phase IIa, participants with end-stage kidney disease will be randomly assigned to receive AZD7760 or a placebo.
- What's involved
- For Phase I, you would have a 28-day screening period, a single IV infusion on Day 1, and then be followed for 12 months. For Phase IIa, you would have a 28-day screening period, two IV infusions given 3 months apart, and then be followed for 12 months after the last infusion.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants in Phase I will be followed for 12 months after receiving the study intervention. Participants in Phase IIa will be followed for 12 months after the last administration of the study intervention.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06749457
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)
Recruiting
PHASE1Ages 18–55InterventionalPreventionAstraZeneca
~231 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:AZD7760Placebo
At a glance
Recruiting sites
39 of 44 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase I: Occurence of adverse events (AEs)
Measured over Day 1 to Day 181
+2 more outcomes measured
Conditions
Where it's being run
44 sites across 21 statesCalifornia13
Florida5
Texas5
Illinois2
Michigan2
North Carolina2
Alabama1
Colorado1
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 per the judgement of the investigator.
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:
Exclusion
Known hypersensitivity to any component of the study intervention
Previous hypersensitivity, infusion-related reaction, or severe adverse reaction following administration of monoclonal antibodies (mAbs).
Clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injections or venipuncture.
Aspartate Aminotransferase (AST) or alanine Aminotransferase (ALT) above 1.5 × upper limit of normal (ULN) at screening. Testing may be repeated once at the investigator's discretion.
Estimated glomerular filtration rate \< 90 mL/min/1.73 m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration equation at screening.
Hemoglobin or platelet count below the lower limit of normal at screening. Testing may be repeated once at the investigator's discretion.
White blood cell counts outside normal reference ranges unless judged by the investigator to be out of range given the known variation in white blood cell count reference interval by ethnicity. Testing may be repeated once at the investigator's discretion.
History of malignancy other than treated non-melanoma skin cancers or locally treated cervical cancer in the previous 5 years.
Any laboratory value in the screening panel that, in the opinion of the investigator, is clinically significant or might confound analysis of study results. Testing may be repeated once at the investigator's discretion.
Any clinically significant abnormalities on 12-lead electrocardiogram (ECG) at screening, as judged by the investigator.
Acute (time-limited) illness, including fever ≥ 38 °C (100.4 °F), one day prior to or on day of planned dosing; participants excluded for transient acute illness may be dosed if illness resolves within the 28-day Screening Period or may be rescreened once.
Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy, including any course of glucocorticoid therapy exceeding 2 weeks of prednisone or equivalent at a dose of 20 mg daily or every other day within 6 months prior to screening.
Any condition that has the potential to increase clearance of the study intervention (eg, protein loss conditions such as severe enteropathies, or plasmapheresis).
Blood drawn in excess of a total of 450 milliliters (mL) (1 unit) for any reason within 2 months prior to screening.
Absence of suitable veins for blood sampling and administration of study intervention.
Any other condition that would compromise safety of the participants.
Any condition that, in the opinion of the investigator, might interfere with evaluation of the study intervention or interpretation of participant safety or study results.
Known hypersensitivity to any component of the study intervention.
History of allergic disease or reactions likely to be exacerbated by any component of the study intervention as listed in dose formulation section.
Previous hypersensitivity, infusion-related reaction, or severe adverse reaction following administration of mAbs.
Hemoglobin \< 9 g/dL at screening considered by the investigator to be due to acute condition(s). Testing may be repeated once at the investigator's discretion.
Serum albumin of \< 3 g/dL at screening considered by the investigator to be due to acute condition(s). Testing may be repeated once at the investigator's discretion.
Myocardial infarction, acute coronary syndrome, stroke, seizure, or a thrombotic/thromboembolic event (eg, deep vein thrombosis or pulmonary embolism, but excluding vascular access thrombosis) within 90 days prior to randomization.
Known S aureus infection within 90 days of study entry.
Known acute viral or bacterial infection or symptoms/signs consistent with such an infection within the 21 days prior to infusion or study intervention. Mild intercurrent viral illness with a temperature of 38.1 °C (100.6 °F) or less does not require exclusion, if in the judgement of the investigator this illness will not interfere with the evaluation of the mAb.
Participants with malignancy undergoing chemotherapy.
Scheduled date for living donor kidney transplant.
Plans to switch to peritoneal dialysis within the primary endpoint time period (181 days).
Regarding arteriovenous fistula (AVF) or arteriovenous graft (AVG):
What this trial measures
- Phase I: Occurence of adverse events (AEs)Day 1 to Day 181
To evaluate the safety of AZD7760 administered as a single intravenous (IV) Dose A, B, or C.
- Phase I: Occurence of medically-attended adverse events (MAAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs)Day 1 to Day 361
To evaluate the safety of AZD7760 administered as a single IV Dose A, B, or C.
- Phase IIa: Occurrence of AEs, MAAEs, SAEs, and AESIsDay 1 to Day 181
To evaluate the safety of AZD7760 compared with placebo as: * A single IV dose (at Day 1) of Dose D followed by placebo (at Day 91) * 2 IV doses (at Day 1 and Day 91) of Dose E