Back to Trials
NCT06749457PHASE1, PHASE2RecruitingAccepts Healthy Volunteers

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)

AstraZeneca

Start Date

12/30/2024

Completion Date

1/7/2028

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).

Detailed 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.

Eligibility Criteria

Age Range: 18 years to 55 years

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.

Interventions

DRUG

AZD7760

OTHER

Placebo

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Staphylococcus Aureus

Locations

Research Site

Huntsville, Alabama 35805

United States

Research Site

Chula Vista, California 91910

United States

Research Site

Chula Vista, California 91910

United States

Research Site

Glendale, California 91206

United States

Research Site

Granada Hills, California 91344

United States

Research Site

Los Angeles, California 90027

United States

Research Site

Northridge, California 91324

United States

Research Site

Northridge, California 91325

United States

Research Site

Oxnard, California 93036

United States

Research Site

Riverside, California 92503

United States

Research Site

San Dimas, California 91773

United States

Research Site

Tarzana, California 91356

United States

Research Site

Valencia, California 91355

United States

Research Site

Victorville, California 92392

United States

Research Site

Englewood, Colorado 80110

United States

Research Site

Bradenton, Florida 34209

United States

Research Site

Coral Springs, Florida 33071

United States

Research Site

Hollywood, Florida 33024

United States

Research Site

Orlando, Florida 32806

United States

Research Site

Tampa, Florida 33603

United States

Research Site

Lawrenceville, Georgia 30046

United States

Research Site

Chicago, Illinois 60640

United States

Research Site

Chicago, Illinois 60643

United States

Research Site

Iowa City, Iowa 52242

United States

Research Site

Lexington, Kentucky 40503

United States

Research Site

Baltimore, Maryland 21225

United States

Research Site

Detroit, Michigan 48202

United States

Research Site

Pontiac, Michigan 48341

United States

Research Site

Tupelo, Mississippi 38801

United States

Research Site

Kansas City, Missouri 64111

United States

Research Site

Lincoln, Nebraska 68510

United States

Research Site

Jersey City, New Jersey 07305

United States

Research Site

Albuquerque, New Mexico 87109

United States

Research Site

Ridgewood, New York 11385

United States

Research Site

Kinston, North Carolina 28504

United States

Research Site

Winston-Salem, North Carolina 27103

United States

Research Site

Bethlehem, Pennsylvania 18017

United States

Research Site

Knoxville, Tennessee 37923

United States

Research Site

Beaumont, Texas 77706

United States

Research Site

Dallas, Texas 75246

United States

Research Site

Houston, Texas 77074

United States

Research Site

McAllen, Texas 78503

United States

Research Site

San Antonio, Texas 78215

United States