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)
NCT ID: NCT06749457
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1/PHASE2
231 participants
INTERVENTIONAL
2024-12-30
2027-07-06
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Randomized, Single Blind, Placebo Controlled Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Oral Doses and Repeat Escalating Oral Doses of GSK2251052 in Healthy Adult Subjects
NCT01262885
Phase 1 Randomized Double-blind Placebo Controlled Study to Evaluate Safety and PK of MEDI3902 in Healthy Adults
NCT02255760
An Open-label, Randomized, Single Period, Parallel-Cohort Study To Evaluate Serum and Pulmonary Pharmacokinetics Following Single and Multiple Dose Administration of Intravenous GSK2251052 in Healthy Adult Subjects
NCT01267968
Safety, Tolerability, Pharmacokinetics of Intravenous RPX2003 (Biapenem) in Healthy Adult Subjects
NCT01702649
Phase 1 Study to Evaluate DDI, PK, Safety, Tolerability of SPR741
NCT03376529
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Phase I: AZD7760 Dose A
Participants will receive a single dose of AZD7760 Dose A intravenously on Day 1.
AZD7760
Participants will receive AZD7760 as a single intravenous infusion.
Phase I: AZD7760 Dose B
Participants will receive a single dose of AZD7760 Dose B intravenously on Day 1.
AZD7760
Participants will receive AZD7760 as a single intravenous infusion.
Phase I: AZD7760 Dose C
Participants will receive a single dose of AZD7760 Dose C intravenously on Day 1.
AZD7760
Participants will receive AZD7760 as a single intravenous infusion.
Phase I: Placebo
Participants will receive a single dose of placebo on Day 1.
Placebo
Participants will be administered placebo through intravenous infusion.
Phase IIa: AZD7760 Dose D and Placebo
Participants will receive AZD7760 Dose D and placebo on Day 1 on Day 91.
AZD7760
Participants will receive AZD7760 as a single intravenous infusion.
Placebo
Participants will be administered placebo through intravenous infusion.
Phase IIa: AZD7760 Dose E
Participants will receive AZD7760 Dose E on Day 1 and Day 91.
AZD7760
Participants will receive AZD7760 as a single intravenous infusion.
Phase IIa: Placebo
Participants will receive placebo on Day 1 and on Day 91.
Placebo
Participants will be administered placebo through intravenous infusion.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AZD7760
Participants will receive AZD7760 as a single intravenous infusion.
Placebo
Participants will be administered placebo through intravenous infusion.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
55 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Parexel
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Site
Huntsville, Alabama, 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
Research Site
Chicago, Illinois, United States
Research Site
Chicago, Illinois, United States
Research Site
Iowa City, Iowa, United States
Research Site
Baltimore, Maryland, United States
Research Site
Detroit, Michigan, United States
Research Site
Pontiac, Michigan, United States
Research Site
Tupelo, Mississippi, United States
Research Site
Kansas City, Missouri, United States
Research Site
Lincoln, Nebraska, United States
Research Site
Jersey City, New Jersey, United States
Research Site
Albuquerque, New Mexico, United States
Research Site
Ridgewood, New York, United States
Research Site
Kinston, North Carolina, United States
Research Site
Winston-Salem, North Carolina, United States
Research Site
Bethlehem, Pennsylvania, United States
Research Site
Knoxville, Tennessee, United States
Research Site
Beaumont, Texas, United States
Research Site
Dallas, Texas, United States
Research Site
Houston, Texas, United States
Research Site
McAllen, Texas, United States
Research Site
San Antonio, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D7480C00001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.