Staphylococcus Aureus Bloodstream Infection
Conditions
Brief summary
The purpose of this study is to evaluate the safety and PK of AZD7760 when given as an intravenous (IV) infusion to healthy Japanese adult participants.
Detailed description
This is a Phase I, randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety and PK of AZD7760, a mAb combination of suvratoxumab (labeled as MEDI4893) and AZD7745, in healthy Japanese adults. Two dosages of AZD7760 each administered as a single IV dose, will be assessed. Study details include: * A Screening Period of up to 28 days. * A Dosing Period of 3 days, in which a single IV infusion will be given on Day 1. * A Follow-up Period of 12 months from the time of administration of the study intervention.
Interventions
DRUGAZD7760
Participants will receive AZD7760 via IV infusion.
OTHERPlacebo
Participants will receive matching placebo via IV infusion.
Sponsors
AstraZeneca
Parexel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Body weight ≥ 45 kg and ≤ 110 kg and BMI within the range of ≥ 18.0 to ≤ 30.0 kg/m2 (inclusive) at screening. * Healthy Japanese participants with no clinically significant concomitant diseases or medications.
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 × ULN at screening. * Estimated glomerular filtration rate \< 90 mL/min/1.73 m2. * Hemoglobin or platelet count below the lower limit of normal at screening. * White blood cell counts outside normal reference ranges. * History of malignancy other than treated non-melanoma skin cancers or locally treated cervical cancer in the previous 5 years. * Any clinically significant abnormalities on 12-lead ECG at screening, * Acute (time-limited) illness, including fever ≥ 38 °C (100.4 °F), 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: 1. 400 mL whole blood donation within 12 weeks (males) or 16 weeks (females) prior to study drug administration. 2. 200 mL whole blood donation within 4 weeks prior to study drug administration. 3. 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 | Description |
|---|---|---|
| Occurrence of Medically-attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs) | Day 1 to Day 361 | To evaluate the safety of AZD7760 administered as a single IV Dose A or Dose B in healthy Japanese adult participants. |
| Occurrence of Adverse Events (AEs) | Day 1 to Day 181 | To evaluate the safety of AZD7760 administered as a single IV Dose A or Dose B in healthy Japanese adult participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to reach peak or maximum observed concentration following drug administration (tmax) | Day 1 to Day 361 | To characterize the PK of AZD7760 in serum of healthy Japanese adult participants. |
| Terminal elimination half-life (t½λz) | Day 1 to Day 361 | To characterize the PK of AZD7760 in serum of healthy Japanese adult participants. |
| Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast) | Day 1 to Day 361 | To characterize the PK of AZD7760 in serum of healthy Japanese adult participants. |
| Area under the concentration-time curve from time 0 to infinity (AUCinf) | Day 1 to Day 361 | To characterize the PK of AZD7760 in serum of healthy Japanese adult participants. |
| Volume of distribution at steady state (Vss) | Day 1 to Day 361 | To characterize the PK of AZD7760 in serum of healthy Japanese adult participants. |
| Incidence of Anti-drug antibody (ADA) | Day 1 to Day 361 | To evaluate ADA responses to AZD7760 in serum of healthy Japanese adult participants |
| Volume of distribution based on the terminal phase (Vz) | Day 1 to Day 361 | To characterize the PK of AZD7760 in serum of healthy Japanese adult participants. |
| Maximum observed serum (peak) drug concentration (Cmax) | Day 1 to Day 361 | To characterize the PK of AZD7760 in serum of healthy Japanese adult participants. |
Countries
Japan
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed