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)

NCT06749457 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: D7480C00001
• Study Type: interventional
• Target: 231
• Locations: 1 country
• Sites: 42

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

Keywords

Bloodstream infection; End-stage kidney disease

Outcome Measures

Primary Outcomes (3)

• Phase I: Occurence of adverse events (AEs)

  To evaluate the safety of AZD7760 administered as a single intravenous (IV) Dose A, B, or C.

  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)

  To evaluate the safety of AZD7760 administered as a single IV Dose A, B, or C.

  Day 1 to Day 361

• Phase IIa: Occurrence of AEs, MAAEs, SAEs, and AESIs

  To evaluate the safety of AZD7760 compared with placebo as: * A single IV dose (at Day 1) of Dose D followed by placebo (at Day 91) * 2 IV doses (at Day 1 and Day 91) of Dose E

  Day 1 to Day 181

Secondary Outcomes (18)

• Phase I: Maximum observed plasma (peak) drug concentration (Cmax)

  Day 1 to Day 361

• Phase I: Time to reach peak or maximum observed concentration following drug administration (tmax)

  Day 1 to Day 361

• Phase I: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz)

  Day 1 to Day 361

• Phase I: Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast)

  Day 1 to Day 361

• Phase I: Area under plasma concentration-time curve from zero extrapolated to infinity (AUCinf)

  Day 1 to Day 361

Study Arms (7)

Phase I: AZD7760 Dose A

EXPERIMENTAL

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

Drug: AZD7760

Phase I: AZD7760 Dose B

EXPERIMENTAL

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

Drug: AZD7760

Phase I: AZD7760 Dose C

EXPERIMENTAL

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

Drug: AZD7760

Phase I: Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Phase IIa: AZD7760 Dose D and Placebo

EXPERIMENTAL

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

Drug: AZD7760; Other: Placebo

Phase IIa: AZD7760 Dose E

EXPERIMENTAL

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

Drug: AZD7760

Phase IIa: Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

AZD7760 DRUG

Participants will receive AZD7760 as a single intravenous infusion.

Phase I: AZD7760 Dose A; Phase I: AZD7760 Dose B; Phase I: AZD7760 Dose C; Phase IIa: AZD7760 Dose D and Placebo; Phase IIa: AZD7760 Dose E

Placebo OTHER

Participants will be administered placebo through intravenous infusion.

Phase I: Placebo; Phase IIa: AZD7760 Dose D and Placebo; Phase IIa: Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• Diagnosed with End-stage kidney disease (ESKD).
• Requiring hemodialysis through a tunneled central venous catheter as the primary vascular access for hemodialysis.
• Receiving hemodialysis for treatment of ESKD for at least 90 days before randomization.
• At least 3 previous dialysis sessions using current dialyzer.
• Receiving adequate hemodialysis based on a single-pool Kt/V measurement \> 1.2 within the last 30 days.
• 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.
• Not taking long-term systemic antibiotics with activity against S aureus.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead
• Parexel: collaborator

Study Sites (42)

Research Site

Huntsville, Alabama, 35805, United States

RECRUITING

Research Site

Chula Vista, California, 91910, United States

WITHDRAWN

Research Site

Chula Vista, California, 91910, United States

RECRUITING

Research Site

Glendale, California, 91206, United States

RECRUITING

Research Site

Granada Hills, California, 91344, United States

RECRUITING

Research Site

Los Angeles, California, 90027, United States

RECRUITING

Research Site

Northridge, California, 91324, United States

RECRUITING

Research Site

Northridge, California, 91325, United States

RECRUITING

Research Site

Oxnard, California, 93036, United States

RECRUITING

Research Site

Riverside, California, 92503, United States

RECRUITING

Research Site

San Dimas, California, 91773, United States

RECRUITING

Research Site

Tarzana, California, 91356, United States

RECRUITING

Research Site

Valencia, California, 91355, United States

RECRUITING

Research Site

Victorville, California, 92392, United States

RECRUITING

Research Site

Englewood, Colorado, 80110, United States

RECRUITING

Research Site

Bradenton, Florida, 34209, United States

RECRUITING

Research Site

Coral Springs, Florida, 33071, United States

RECRUITING

Research Site

Hollywood, Florida, 33024, United States

RECRUITING

Research Site

Orlando, Florida, 32806, United States

RECRUITING

Research Site

Tampa, Florida, 33603, United States

RECRUITING

Research Site

Lawrenceville, Georgia, 30046, United States

NOT YET RECRUITING

Research Site

Chicago, Illinois, 60640, United States

RECRUITING

Research Site

Chicago, Illinois, 60643, United States

RECRUITING

Research Site

Iowa City, Iowa, 52242, United States

RECRUITING

Research Site

Baltimore, Maryland, 21225, United States

RECRUITING

Research Site

Detroit, Michigan, 48202, United States

RECRUITING

Research Site

Pontiac, Michigan, 48341, United States

RECRUITING

Research Site

Tupelo, Mississippi, 38801, United States

RECRUITING

Research Site

Kansas City, Missouri, 64111, United States

RECRUITING

Research Site

Lincoln, Nebraska, 68510, United States

RECRUITING

Research Site

Jersey City, New Jersey, 07305, United States

RECRUITING

Research Site

Albuquerque, New Mexico, 87109, United States

RECRUITING

Research Site

Ridgewood, New York, 11385, United States

RECRUITING

Research Site

Kinston, North Carolina, 28504, United States

WITHDRAWN

Research Site

Winston-Salem, North Carolina, 27103, United States

RECRUITING

Research Site

Bethlehem, Pennsylvania, 18017, United States

RECRUITING

Research Site

Knoxville, Tennessee, 37923, United States

WITHDRAWN

Research Site

Beaumont, Texas, 77706, United States

RECRUITING

Research Site

Dallas, Texas, 75246, United States

RECRUITING

Research Site

Houston, Texas, 77074, United States

RECRUITING

Research Site

McAllen, Texas, 78503, United States

RECRUITING

Research Site

San Antonio, Texas, 78215, United States

WITHDRAWN

MeSH Terms

Conditions

Staphylococcal Infections; Sepsis; Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: December 27, 2024
• Study Start: December 30, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): September 9, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

US (42)