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Evaluating the safety and pharmacokinetics of AZD7760 in healthy adults and those with end-stage kidney disease on hemodialysis

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

Phase1; Phase2 Interventional AstraZeneca · NCT06749457

This study is testing a new drug called AZD7760 to see if it's safe and how it works in healthy adults and those with end-stage kidney disease who are on hemodialysis.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment231 (estimated)
Ages18 Years to 55 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionschemotherapy, prednisone
Locations42 sites (Huntsville, Alabama and 41 other locations)
Trial IDNCT06749457 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and pharmacokinetics of AZD7760, administered as an intravenous infusion, in two phases. In Phase I, healthy participants will receive one of three dosages of AZD7760 or a placebo in a randomized manner. Phase IIa will involve adults with end-stage kidney disease on hemodialysis, who will also be randomized to receive either AZD7760 or placebo in two infusions spaced three months apart. Participants will be monitored for safety and efficacy over a follow-up period of 12 months.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with end-stage kidney disease requiring hemodialysis through a central venous catheter.

Not a fit: Patients who are not on hemodialysis or do not have end-stage kidney disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with bloodstream infections related to end-stage kidney disease.

How similar studies have performed: Other studies have shown promise with similar pharmacokinetic evaluations, but this specific approach with AZD7760 is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Huntsville, Alabama and 41 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Staphylococcus AureusBloodstream infectionEnd-stage kidney disease
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.