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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

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)

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

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) (NCT06749457) is a Phase 1 / Phase 2 interventional studying Staphylococcus Aureus, sponsored by AstraZeneca. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Staphylococcus Aureus, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 231 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Staphylococcus Aureus subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: Phase I: - Participant must be 18 to 55 years of age (inclusive), at the time of signing the willing to sign a consent form. - 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 perthe judgement of the investigator. Phase IIa: - Participant must be ≥ 18 years of age at the time of signing the willing to sign a consent form. - Participants who meet all of the following disease status requirements: 1. Diagnosed with End-stage kidney disease (ESKD). 2. Requiring hemodialysis through a tunneled central venous catheter as the primary vascular access for hemodialysis. 3. Receiving hemodialysis for treatment of ESKD for at least 90 days before randomization. 4. At least 3 previous dialysis sessions using current dialyzer. 5. Receiving adequate hemodialysis based on a single-pool Kt/V measurement \> 1.2 within the last 30 days. 6. No new medications have been added to the participant's regimen in the last 2 weeks prior to dosing. 'New medication' is defined as any medication that has not been prescribed or used by the participant previously (including formulation changes). Medication previously prescribed or used by the participant with dose adjustments is allowed and not considered as new medication for the purpose of this study. 7. Not taking long-term systemic antibiotics with activity against S aureus. Who Should NOT Join This Trial: Phase I: - Known hypersensitivity to any component of the study intervention - Previous hypersensitivity, infusion-related reaction, or severe adverse reaction following administration of monoclonal antibodies (mAbs). ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: Phase I: * 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 perthe judgement of the investigator. Phase IIa: * 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: 1. Diagnosed with End-stage kidney disease (ESKD). 2. Requiring hemodialysis through a tunneled central venous catheter as the primary vascular access for hemodialysis. 3. Receiving hemodialysis for treatment of ESKD for at least 90 days before randomization. 4. At least 3 previous dialysis sessions using current dialyzer. 5. Receiving adequate hemodialysis based on a single-pool Kt/V measurement \> 1.2 within the last 30 days. 6. No new medications have been added to the participant's regimen in the last 2 weeks prior to dosing. 'New medication' is defined as any medication that has not been prescribed or used by the participant previously (including formulation changes). Medication previously prescribed or used by the participant with dose adjustments is allowed and not considered as new medication for the purpose of this study. 7. Not taking long-term systemic antibiotics with activity against S aureus. Exclusion Criteria: Phase I: * 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. Phase IIa: * 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). * Participants with a scheduled calendar date for transition to arteriovenous graft or arteriovenous graft in place and maturing. * Participants with a scheduled calendar date for transition to arteriovenous fistula, or arteriovenous fistula in place and maturing, with anticipated use of fistula within 90 days.

Treatments Being Tested

DRUG

AZD7760

Participants will receive AZD7760 as a single intravenous infusion.

OTHER

Placebo

Participants will be administered placebo through intravenous infusion.

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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
Research Site
San Dimas, California, United States
Research Site
Tarzana, California, United States
Research Site
Valencia, California, United States
Research Site
Victorville, California, United States
Research Site
Englewood, Colorado, United States
Research Site
Bradenton, Florida, United States
Research Site
Coral Springs, Florida, United States
Research Site
Hollywood, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Tampa, Florida, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06749457), the sponsor (AstraZeneca), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06749457 clinical trial studying?

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). The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06749457?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06749457?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06749457. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06749457. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.