Phase
Condition
Staphylococcal Infections
Soft Tissue Infections
Treatment
AZD7760
Placebo
Clinical Study ID
Ages 18-55 All Genders Accepts Healthy Volunteers
Study Summary
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:
Diagnosed with End-stage kidney disease (ESKD).
Requiring hemodialysis through a tunneled central venous catheter as theprimary vascular access for hemodialysis.
Receiving hemodialysis for treatment of ESKD for at least 90 days beforerandomization.
At least 3 previous dialysis sessions using current dialyzer.
Receiving adequate hemodialysis based on a single-pool Kt/V measurement > 1.2within the last 30 days.
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.
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
Study Description
Connect with a study center
Research Site
Huntsville, Alabama 35805
United StatesActive - Recruiting
Research Site
Huntsville 4068590, Alabama 4829764 35805
United StatesSite Not Available
Research Site
Chula Vista, California 91910
United StatesActive - Recruiting
Research Site
Glendale, California 91206
United StatesActive - Recruiting
Research Site
Granada Hills, California 91344
United StatesActive - Recruiting
Research Site
La Mesa, California 91942
United StatesSite Not Available
Research Site
Los Angeles, California 90027
United StatesActive - Recruiting
Research Site
Northridge, California 91324
United StatesActive - Recruiting
Research Site
Oxnard, California 93036
United StatesActive - Recruiting
Research Site
Riverside, California 92503
United StatesActive - Recruiting
Research Site
San Dimas, California 91773
United StatesActive - Recruiting
Research Site
Tarzana, California 91356
United StatesActive - Recruiting
Research Site
Valencia, California 91355
United StatesActive - Recruiting
Research Site
Victorville, California 92392
United StatesActive - Recruiting
Research Site
Chula Vista 5336899, California 5332921 91910
United StatesSite Not Available
Research Site
Glendale 5352423, California 5332921 91206
United StatesSite Not Available
Research Site
Granada Hills 5353433, California 5332921 91344
United StatesSite Not Available
Research Site
La Mesa 5363990, California 5332921 91942
United StatesSite Not Available
Research Site
Los Angeles 5368361, California 5332921 90027
United StatesSite Not Available
Research Site
Northridge 5377985, California 5332921 91324
United StatesSite Not Available
Research Site
Oxnard 5380184, California 5332921 93036
United StatesSite Not Available
Research Site
Riverside 5387877, California 5332921 92503
United StatesSite Not Available
Research Site
San Dimas 5391891, California 5332921 91773
United StatesSite Not Available
Research Site
Tarzana 5401143, California 5332921 91356
United StatesSite Not Available
Research Site
Valencia 5405288, California 5332921 91355
United StatesSite Not Available
Research Site
Victorville 5406222, California 5332921 92392
United StatesSite Not Available
Research Site
Englewood, Colorado 80110
United StatesActive - Recruiting
Research Site
Englewood 5421250, Colorado 5417618 80110
United StatesSite Not Available
Research Site
Bradenton, Florida 34209
United StatesActive - Recruiting
Research Site
Coral Springs, Florida 33071
United StatesActive - Recruiting
Research Site
Hollywood, Florida 33024
United StatesActive - Recruiting
Research Site
Orlando, Florida 32806
United StatesActive - Recruiting
Research Site
Tampa, Florida 33603
United StatesActive - Recruiting
Research Site
Bradenton 4148708, Florida 4155751 34209
United StatesSite Not Available
Research Site
Coral Springs 4151909, Florida 4155751 33071
United StatesSite Not Available
Research Site
Hollywood 4158928, Florida 4155751 33024
United StatesSite Not Available
Research Site
Orlando 4167147, Florida 4155751 32806
United StatesSite Not Available
Research Site
Tampa 4174757, Florida 4155751 33603
United StatesSite Not Available
Research Site
Lawrenceville, Georgia 30046
United StatesSite Not Available
Research Site
Chicago, Illinois 60643
United StatesActive - Recruiting
Research Site
Chicago 4887398, Illinois 4896861 60643
United StatesSite Not Available
Research Site
Iowa City, Iowa 52242
United StatesActive - Recruiting
Research Site
Iowa City 4862034, Iowa 4862182 52242
United StatesSite Not Available
Research Site
Baltimore, Maryland 21225
United StatesActive - Recruiting
Research Site
Baltimore 4347778, Maryland 4361885 21225
United StatesSite Not Available
Research Site
Detroit, Michigan 48202
United StatesActive - Recruiting
Research Site
Pontiac, Michigan 48341
United StatesActive - Recruiting
Research Site
Detroit 4990729, Michigan 5001836 48202
United StatesSite Not Available
Research Site
Pontiac 5006166, Michigan 5001836 48341
United StatesSite Not Available
Research Site
Tupelo, Mississippi 38801
United StatesActive - Recruiting
Research Site
Tupelo 4448903, Mississippi 4436296 38801
United StatesSite Not Available
Research Site
Kansas City, Missouri 64111
United StatesActive - Recruiting
Research Site
Kansas City 4393217, Missouri 4398678 64111
United StatesSite Not Available
Research Site
Lincoln, Nebraska 68510
United StatesActive - Recruiting
Research Site
Lincoln 5072006, Nebraska 5073708 68510
United StatesSite Not Available
Research Site
Jersey City, New Jersey 07305
United StatesActive - Recruiting
Research Site
Jersey City 5099836, New Jersey 5101760 07305
United StatesSite Not Available
Research Site
Albuquerque, New Mexico 87109
United StatesActive - Recruiting
Research Site
Albuquerque 5454711, New Mexico 5481136 87109
United StatesSite Not Available
Research Site
Ridgewood, New York 11385
United StatesActive - Recruiting
Research Site
Ridgewood 5133858, New York 5128638 11385
United StatesSite Not Available
Research Site
Kinston, North Carolina 28504
United StatesSite Not Available
Research Site
Winston-Salem, North Carolina 27103
United StatesActive - Recruiting
Research Site
Kinston 4474436, North Carolina 4482348 28504
United StatesSite Not Available
Research Site
Winston-Salem 4499612, North Carolina 4482348 27103
United StatesSite Not Available
Research Site
Bethlehem, Pennsylvania 18017
United StatesActive - Recruiting
Research Site
Bethlehem 5180225, Pennsylvania 6254927 18017
United StatesSite Not Available
Research Site
Knoxville, Tennessee 37923
United StatesSite Not Available
Research Site
Knoxville 4634946, Tennessee 4662168 37923
United StatesSite Not Available
Research Site
Beaumont, Texas 77706
United StatesActive - Recruiting
Research Site
Dallas, Texas 75246
United StatesActive - Recruiting
Research Site
Houston, Texas 77074
United StatesActive - Recruiting
Research Site
McAllen, Texas 78503
United StatesActive - Recruiting
Research Site
San Antonio, Texas 78215
United StatesSite Not Available
Research Site
Beaumont 4672989, Texas 4736286 77706
United StatesSite Not Available
Research Site
Dallas 4684888, Texas 4736286 75246
United StatesSite Not Available
Research Site
Houston 4699066, Texas 4736286 77074
United StatesSite Not Available
Research Site
McAllen 4709796, Texas 4736286 78503
United StatesSite Not Available
Research Site
San Antonio 4726206, Texas 4736286 78215
United StatesSite Not Available

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