Staphylococcus Aureus Bloodstream Infection
Conditions
Interventions
Healthy participants will be randomised in each cohort to either AZD7760 or placebo administered IV, across 2 dose cohorts.
Sponsors
Ageishi Yuji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Body weight >_ 45 kg and _ 18.0 to <_ 30.0 kg/m2 (inclusive) at screening. - Healthy Japanese participants with no clinically significant concomitant diseases or medications.
Exclusion criteria
Exclusion criteria: - Known hypersensitivity to any component of the study intervention. - Previous hypersensitivity, infusion-related reaction, or severe adverse reaction following administration of mAbs. - Clinically significant bleeding disorder or prior history of significant bleeding or bruising following intramuscular injections or venipuncture. - AST or ALT above 1.5 x ULN at screening. - Estimated glomerular filtration rate _ 38C (100.4F), one day prior to or on the day of planned dosing. - Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy. - Any condition that has the potential to increase clearance of the study intervention. - Blood donation or collection as follows: (a) 400 mL whole blood donation within 12 weeks (males) or 16 weeks (females) prior to study drug administration. (b) 200 mL whole blood donation within 4 weeks prior to study drug administration. (c) Apheresis donation within 2 weeks prior to study drug administration. - Absence of suitable veins for blood sampling and administration of study intervention. - Any other condition that would compromise the safety of the participants. - Any condition that might interfere with evaluation of the study intervention or interpretation of participant safety or study results. - 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Occurrence of AEs through Day 181 - Occurence of MAAEs, SAEs, and AESIs through Day 361 | — |
Contacts
Public ContactYuji Ageishi
Astrazeneka K.K
Outcome results
None listed