A Study to Evaluate the Safety and Pharmacokinetics of AZD7760 in Healthy Japanese Adults
Recruiting now · Phase 1 · Has a placebo group
Conditions studied: Staphylococcus Aureus Bloodstream Infection
In brief
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.
Key facts
- Study ID
- NCT07612813
- Run by
- AstraZeneca
- People needed
- 18
- Starts
- 2026-06-29
- Expected to finish
- 2027-09-13
- Last updated by the study team
- 2026-07-14
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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:
- 400 mL whole blood donation within 12 weeks (males) or 16 weeks (females) prior to study drug administration.
- 200 mL whole blood donation within 4 weeks prior to study drug administration.
- 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.
Where it is running
- Research Site — Sumida-ku, Japan (enrolling)
Full record on ClinicalTrials.gov
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