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)

Last updated: April 30, 2026
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

1/2

Condition

Staphylococcal Infections

Soft Tissue Infections

Treatment

AZD7760

Placebo

Clinical Study ID

NCT06749457
D7480C00001
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

Phase I:

  • Participant must be 18 to 55 years of age (inclusive), at the time of signing theinformed consent.

  • Body weight ≥ 45 kilograms (kg) and ≤ 110 kg and Body Mass Index (BMI) within therange ≥ 18.0 to ≤ 30.0 kilograms per square meter (kg/m2) (inclusive) at screening.

  • Healthy participants with no clinically significant concomitant diseases ormedications (except for those specifically permitted by the protocol) according tomedical history, physical examination, screening safety laboratory tests, andscreening 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 theprimary vascular access for hemodialysis.

  3. Receiving hemodialysis for treatment of ESKD for at least 90 days beforerandomization.

  4. At least 3 previous dialysis sessions using current dialyzer.

  5. Receiving adequate hemodialysis based on a single-pool Kt/V measurement > 1.2within the last 30 days.

  6. No new medications have been added to the participant's regimen in the last 2weeks prior to dosing. 'New medication' is defined as any medication that hasnot been prescribed or used by the participant previously (includingformulation changes). Medication previously prescribed or used by theparticipant with dose adjustments is allowed and not considered as newmedication for the purpose of this study.

  7. Not taking long-term systemic antibiotics with activity against S aureus.

Exclusion

Exclusion Criteria:

Phase I:

  • Known hypersensitivity to any component of the study intervention

  • Previous hypersensitivity, infusion-related reaction, or severe adverse reactionfollowing administration of monoclonal antibodies (mAbs).

  • Clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, orplatelet disorder), or prior history of significant bleeding or bruising followingintramuscular injections or venipuncture.

  • Aspartate Aminotransferase (AST) or alanine Aminotransferase (ALT) above 1.5 × upperlimit of normal (ULN) at screening. Testing may be repeated once at theinvestigator's discretion.

  • Estimated glomerular filtration rate < 90 mL/min/1.73 m2 calculated using theChronic Kidney Disease Epidemiology Collaboration equation at screening.

  • Hemoglobin or platelet count below the lower limit of normal at screening. Testingmay be repeated once at the investigator's discretion.

  • White blood cell counts outside normal reference ranges unless judged by theinvestigator to be out of range given the known variation in white blood cell countreference interval by ethnicity. Testing may be repeated once at the investigator'sdiscretion.

  • History of malignancy other than treated non-melanoma skin cancers or locallytreated cervical cancer in the previous 5 years.

  • Any laboratory value in the screening panel that, in the opinion of theinvestigator, 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) atscreening, as judged by the investigator.

  • Acute (time-limited) illness, including fever ≥ 38 °C (100.4 °F), one day prior toor on day of planned dosing; participants excluded for transient acute illness maybe dosed if illness resolves within the 28-day Screening Period or may be rescreenedonce.

  • Known or suspected congenital or acquired immunodeficiency, or receipt ofimmunosuppressive therapy, including any course of glucocorticoid therapy exceeding 2 weeks of prednisone or equivalent at a dose of 20 mg daily or every other daywithin 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 reasonwithin 2 months prior to screening.

  • Absence of suitable veins for blood sampling and administration of studyintervention.

  • Any other condition that would compromise safety of the participants.

  • Any condition that, in the opinion of the investigator, might interfere withevaluation of the study intervention or interpretation of participant safety orstudy results.

Phase IIa:

  • Known hypersensitivity to any component of the study intervention.

  • History of allergic disease or reactions likely to be exacerbated by any componentof the study intervention as listed in dose formulation section.

  • Previous hypersensitivity, infusion-related reaction, or severe adverse reactionfollowing administration of mAbs.

  • Hemoglobin < 9 g/dL at screening considered by the investigator to be due to acutecondition(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 toacute condition(s). Testing may be repeated once at the investigator's discretion.

  • Myocardial infarction, acute coronary syndrome, stroke, seizure, or athrombotic/thromboembolic event (eg, deep vein thrombosis or pulmonary embolism, butexcluding 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 aninfection within the 21 days prior to infusion or study intervention. Mildintercurrent viral illness with a temperature of 38.1 °C (100.6 °F) or less does notrequire exclusion, if in the judgement of the investigator this illness will notinterfere 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 (181days).

  • Participants with a scheduled calendar date for transition to arteriovenous graft orarteriovenous 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 fistulawithin 90 days.

Study Design

Total Participants: 231
Treatment Group(s): 2
Primary Treatment: AZD7760
Phase: 1/2
Study Start date:
December 30, 2024
Estimated Completion Date:
September 09, 2027

Study Description

In the Phase I portion of the study, participants will be randomized to receive one of 3 dosages of AZD7760 or placebo as a single intravenous infusion.

Study details include:

  • A 28-day Screening Period.

  • A Dosing Period of 3 days in which a single intravenous infusion will be given on Day 1.

  • A Follow-up Period of 12 months from the time of administration of the study intervention.

In the Phase IIa portion of the study, participants will be randomized to receive either AZD7760 or placebo as 2 intravenous infusions given 3 months apart.

Study details include:

  • A 28-day Screening Period.

  • A Dosing Period in which 2 intravenous infusions will be given 3 months apart (Day 1 and Day 91).

  • A Follow-up Period of 12 months after the last administration of the study intervention on Day 91.

Connect with a study center

  • Research Site

    Huntsville, Alabama 35805
    United States

    Active - Recruiting

  • Research Site

    Huntsville 4068590, Alabama 4829764 35805
    United States

    Site Not Available

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    Chula Vista, California 91910
    United States

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  • Research Site

    Glendale, California 91206
    United States

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  • Research Site

    Granada Hills, California 91344
    United States

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  • Research Site

    La Mesa, California 91942
    United States

    Site Not Available

  • Research Site

    Los Angeles, California 90027
    United States

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    Northridge, California 91324
    United States

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    Oxnard, California 93036
    United States

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    Riverside, California 92503
    United States

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  • Research Site

    San Dimas, California 91773
    United States

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    Tarzana, California 91356
    United States

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  • Research Site

    Valencia, California 91355
    United States

    Active - Recruiting

  • Research Site

    Victorville, California 92392
    United States

    Active - Recruiting

  • Research Site

    Chula Vista 5336899, California 5332921 91910
    United States

    Site Not Available

  • Research Site

    Glendale 5352423, California 5332921 91206
    United States

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  • Research Site

    Granada Hills 5353433, California 5332921 91344
    United States

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  • Research Site

    La Mesa 5363990, California 5332921 91942
    United States

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  • Research Site

    Los Angeles 5368361, California 5332921 90027
    United States

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  • Research Site

    Northridge 5377985, California 5332921 91324
    United States

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  • Research Site

    Oxnard 5380184, California 5332921 93036
    United States

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  • Research Site

    Riverside 5387877, California 5332921 92503
    United States

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  • Research Site

    San Dimas 5391891, California 5332921 91773
    United States

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  • Research Site

    Tarzana 5401143, California 5332921 91356
    United States

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  • Research Site

    Valencia 5405288, California 5332921 91355
    United States

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  • Research Site

    Victorville 5406222, California 5332921 92392
    United States

    Site Not Available

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    Englewood, Colorado 80110
    United States

    Active - Recruiting

  • Research Site

    Englewood 5421250, Colorado 5417618 80110
    United States

    Site Not Available

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    Bradenton, Florida 34209
    United States

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    Coral Springs, Florida 33071
    United States

    Active - Recruiting

  • Research Site

    Hollywood, Florida 33024
    United States

    Active - Recruiting

  • Research Site

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • Research Site

    Tampa, Florida 33603
    United States

    Active - Recruiting

  • Research Site

    Bradenton 4148708, Florida 4155751 34209
    United States

    Site Not Available

  • Research Site

    Coral Springs 4151909, Florida 4155751 33071
    United States

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  • Research Site

    Hollywood 4158928, Florida 4155751 33024
    United States

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  • Research Site

    Orlando 4167147, Florida 4155751 32806
    United States

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  • Research Site

    Tampa 4174757, Florida 4155751 33603
    United States

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    Lawrenceville, Georgia 30046
    United States

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  • Research Site

    Chicago, Illinois 60643
    United States

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  • Research Site

    Chicago 4887398, Illinois 4896861 60643
    United States

    Site Not Available

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    Iowa City, Iowa 52242
    United States

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  • Research Site

    Iowa City 4862034, Iowa 4862182 52242
    United States

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    Baltimore, Maryland 21225
    United States

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  • Research Site

    Baltimore 4347778, Maryland 4361885 21225
    United States

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    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Research Site

    Pontiac, Michigan 48341
    United States

    Active - Recruiting

  • Research Site

    Detroit 4990729, Michigan 5001836 48202
    United States

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    Pontiac 5006166, Michigan 5001836 48341
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    Tupelo, Mississippi 38801
    United States

    Active - Recruiting

  • Research Site

    Tupelo 4448903, Mississippi 4436296 38801
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  • Research Site

    Kansas City, Missouri 64111
    United States

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  • Research Site

    Kansas City 4393217, Missouri 4398678 64111
    United States

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    Lincoln, Nebraska 68510
    United States

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  • Research Site

    Lincoln 5072006, Nebraska 5073708 68510
    United States

    Site Not Available

  • Research Site

    Jersey City, New Jersey 07305
    United States

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  • Research Site

    Jersey City 5099836, New Jersey 5101760 07305
    United States

    Site Not Available

  • Research Site

    Albuquerque, New Mexico 87109
    United States

    Active - Recruiting

  • Research Site

    Albuquerque 5454711, New Mexico 5481136 87109
    United States

    Site Not Available

  • Research Site

    Ridgewood, New York 11385
    United States

    Active - Recruiting

  • Research Site

    Ridgewood 5133858, New York 5128638 11385
    United States

    Site Not Available

  • Research Site

    Kinston, North Carolina 28504
    United States

    Site Not Available

  • Research Site

    Winston-Salem, North Carolina 27103
    United States

    Active - Recruiting

  • Research Site

    Kinston 4474436, North Carolina 4482348 28504
    United States

    Site Not Available

  • Research Site

    Winston-Salem 4499612, North Carolina 4482348 27103
    United States

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  • Research Site

    Bethlehem, Pennsylvania 18017
    United States

    Active - Recruiting

  • Research Site

    Bethlehem 5180225, Pennsylvania 6254927 18017
    United States

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    Knoxville, Tennessee 37923
    United States

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    Knoxville 4634946, Tennessee 4662168 37923
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    Beaumont, Texas 77706
    United States

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    Dallas, Texas 75246
    United States

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    Houston, Texas 77074
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    McAllen, Texas 78503
    United States

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    San Antonio, Texas 78215
    United States

    Site Not Available

  • Research Site

    Beaumont 4672989, Texas 4736286 77706
    United States

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  • Research Site

    Dallas 4684888, Texas 4736286 75246
    United States

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  • Research Site

    Houston 4699066, Texas 4736286 77074
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  • Research Site

    McAllen 4709796, Texas 4736286 78503
    United States

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  • Research Site

    San Antonio 4726206, Texas 4736286 78215
    United States

    Site Not Available

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