Recruiting
Phase 1
Phase 2

AZD7760

Sponsor:

AstraZeneca

Code:

NCT06749457

Conditions

Staphylococcus Aureus

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

AZD7760

Placebo

Study Details

Brief 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).

Conditions

Staphylococcus Aureus

Study ID

NCT06749457

Start date

Dec 30, 2024

Status verified date

Aug, 2026

Completion date

Jan 7, 2028

Anticipated

Primary completion date

Apr 2, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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 per the 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 60 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).
  • Regarding arteriovenous fistula (AVF) or arteriovenous graft (AVG):

(a) Future AVG or AVG: (i) Participants with central venous catheters currently in use for dialysis, and future plans for AVF or AVG use within 90 days of randomization are not eligible.

(ii) Participants with central venous catheters currently in use for dialysis, and future plans for AVF or AVG placement, but no plans for AVF or AVG use within 90 days of randomization are eligible.

(b) Existing AVG or AVG: (i) Participants with central venous catheters in use for dialysis, but also with an existing AVF or AVG that is not in use and with no future plans for use are eligible.

Study Design

Enrollment

231 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Phase I: AZD7760 Dose A

Participants will receive a single dose of AZD7760 Dose A intravenously on Day 1.

experimental: Phase I: AZD7760 Dose B

Participants will receive a single dose of AZD7760 Dose B intravenously on Day 1.

experimental: Phase I: AZD7760 Dose C

Participants will receive a single dose of AZD7760 Dose C intravenously on Day 1.

placebo comparator: Phase I: Placebo

Participants will receive a single dose of placebo on Day 1.

experimental: Phase IIa: AZD7760 Dose D and Placebo

Participants will receive AZD7760 Dose D and placebo on Day 1 on Day 91.

experimental: Phase IIa: AZD7760 Dose E

Participants will receive AZD7760 Dose E on Day 1 and Day 91.

placebo comparator: Phase IIa: Placebo

Participants will receive placebo on Day 1 and on Day 91.

Interventions

AZD7760

Participants will receive AZD7760 as a single intravenous infusion.

Placebo

Participants will be administered placebo through intravenous infusion.

Primary outcome measure

  • Phase I: Occurence of adverse events (AEs) [ Time Frame: Day 1 to Day 181 ]
  • Phase I: Occurence of medically-attended adverse events (MAAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) [ Time Frame: Day 1 to Day 361 ]
  • Phase IIa: Occurrence of AEs, MAAEs, SAEs, and AESIs [ Time Frame: Day 1 to Day 181 ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

Huntsville, Alabama, United States, 35805

Research Site

Recruiting

Chula Vista, California, United States, 91910

Research Site

Recruiting

Glendale, California, United States, 91206

Research Site

Recruiting

Granada Hills, California, United States, 91344

Research Site

Recruiting

Los Angeles, California, United States, 90027

Research Site

Recruiting

Northridge, California, United States, 91324

Research Site

Recruiting

Northridge, California, United States, 91325

Research Site

Recruiting

Oxnard, California, United States, 93036

Research Site

Recruiting

Riverside, California, United States, 92503

Research Site

Recruiting

San Dimas, California, United States, 91773

Research Site

Recruiting

Tarzana, California, United States, 91356

Research Site

Recruiting

Valencia, California, United States, 91355

Research Site

Recruiting

Victorville, California, United States, 92392

Research Site

Recruiting

Englewood, Colorado, United States, 80110

Research Site

Recruiting

Bradenton, Florida, United States, 34209

Research Site

Recruiting

Coral Springs, Florida, United States, 33071

Research Site

Recruiting

Hollywood, Florida, United States, 33024

Research Site

Recruiting

Orlando, Florida, United States, 32806

Research Site

Recruiting

Tampa, Florida, United States, 33603

Research Site

Recruiting

Lawrenceville, Georgia, United States, 30046

Research Site

Recruiting

Chicago, Illinois, United States, 60640

Research Site

Recruiting

Chicago, Illinois, United States, 60643

Research Site

Recruiting

Iowa City, Iowa, United States, 52242

Research Site

Recruiting

Lexington, Kentucky, United States, 40503

Research Site

Recruiting

Baltimore, Maryland, United States, 21225

Research Site

Recruiting

Detroit, Michigan, United States, 48202

Research Site

Recruiting

Pontiac, Michigan, United States, 48341

Research Site

Recruiting

Tupelo, Mississippi, United States, 38801

Research Site

Recruiting

Kansas City, Missouri, United States, 64111

Research Site

Recruiting

Lincoln, Nebraska, United States, 68510

Research Site

Recruiting

Jersey City, New Jersey, United States, 07305

Research Site

Recruiting

Albuquerque, New Mexico, United States, 87109

Research Site

Recruiting

Ridgewood, New York, United States, 11385

Research Site

Recruiting

Winston-Salem, North Carolina, United States, 27103

Research Site

Recruiting

Bethlehem, Pennsylvania, United States, 18017

Research Site

Recruiting

Beaumont, Texas, United States, 77706

Research Site

Recruiting

Dallas, Texas, United States, 75246

Research Site

Recruiting

Houston, Texas, United States, 77074

Research Site

Recruiting

McAllen, Texas, United States, 78503

More Information

Sponsor

AstraZeneca

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

  • Bloodstream infection
  • End-stage kidney disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-08-14.