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Tests treatment safety and results for Staphylococcus Aureus
Official title 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)
ClinicalTrials.gov ID: NCT06749457
What this study is testing
What is AZD7760?
AZD7760 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for staphylococcus aureus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join 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)...
- Healthy participants with no clinically significant concomitant diseases or medications (except for those specifically permitted by the protocol)...
- Participant must be ≥ 18 years of age at the time of signing the informed consent.
You likely can't join 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...
- Aspartate Aminotransferase (AST) or alanine Aminotransferase (ALT) above 1.5 × upper limit of normal (ULN) at screening. Testing may be repeated once...
- Estimated glomerular filtration rate \< 90 mL/min/1.73 m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration equation at...
See the full eligibility criteria
Who can join
- 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...
- 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...
- Not taking long-term systemic antibiotics with activity against S aureus.
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Huntsville, Alabama, United States
- Chula Vista, California, United States
- Glendale, California, United States
- Granada Hills, California, United States
- Los Angeles, California, United States
- Northridge, California, United States
- Oxnard, California, United States
- Riverside, California, United States
- San Dimas, California, United States
- Tarzana, California, United States
- Valencia, California, United States
- Victorville, California, United States
- Englewood, Colorado, United States
- Bradenton, Florida, United States
- Coral Springs, Florida, United States
- Hollywood, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Lawrenceville, Georgia, United States
- Chicago, Illinois, United States
+ 20 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Huntsville, Alabama, United States; Chula Vista, California, United States; Glendale, California, United States; Granada Hills, California, United States; Los Angeles, California, United States; Northridge, California, United States and 34 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.