JRCT ID: jRCT2071260039
Registered date:09/06/2026
A Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetics of AZD7760 in Healthy Japanese Adult Participants
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | Staphylococcus Aureus Bloodstream Infection |
| Date of first enrollment | 29/06/2026 |
| Target sample size | 18 |
| Countries of recruitment | |
| Study type | Interventional |
| Intervention(s) | Healthy participants will be randomised in each cohort to either AZD7760 or placebo administered IV, across 2 dose cohorts. |
Outcome(s)
| Primary Outcome | - Occurrence of AEs through Day 181 - Occurence of MAAEs, SAEs, and AESIs through Day 361 |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | >= 18age old |
|---|---|
| Age maximum | <= 55age old |
| Gender | Both |
| Include 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. |
| Exclude 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 < 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 >_ 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. |
Related Information
| Primary Sponsor | Ageishi Yuji |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | |
| Secondary ID(s) | NCT07612813 |
Contact
| Public contact | |
| Name | Yuji Ageishi |
| Address | 3-1, Ofuka-cho, Kita-ku, Osaka-shi, Osaka Osaka Japan 530-0011 |
| Telephone | +81-6-4802-3600 |
| RD-clinical-information-Japan@astrazeneca.com | |
| Affiliation | Astrazeneka K.K |
| Scientific contact | |
| Name | Yuji Ageishi |
| Address | 3-1, Ofuka-cho, Kita-ku, Osaka-shi, Osaka Osaka Japan 530-0011 |
| Telephone | +81-6-4802-3600 |
| RD-clinical-information-Japan@astrazeneca.com | |
| Affiliation | Astrazeneka K.K |