Staphylococcus Aureus Bloodstream InfectionPhase 1NCT07612813
A Study to Evaluate the Safety and Pharmacokinetics of AZD7760 in Healthy Japanese Adults
A Phase 1 study testing AZD7760 in people with Staphylococcus Aureus Bloodstream Infection, run by AstraZeneca at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Staphylococcus Aureus Bloodstream Infection
- What is being tested?
- AZD7760
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteJapan
- Study dates
- 29 Jun 2026to 13 Sep 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetics of AZD7760 in Healthy Japanese Adult Participants
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.
Read the 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.
- Being tested
- AZD7760, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD7760Drug
Participants will receive AZD7760 via IV infusion.
PlaceboOther
Participants will receive matching placebo via IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 (AZD7760 Dose A) | Experimental | Participants receive an IV infusion of AZD7760 Dose A on Day 1. Receives: Drug: AZD7760 |
| Cohort 2 (AZD7760 Dose B) | Experimental | Participants receive an IV infusion of AZD7760 Dose B on Day 1. Receives: Drug: AZD7760 |
| Pooled Placebo | Placebo comparator | Participants receive an IV infusion of matching placebo on Day 1. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Adverse Events (AEs)
To evaluate the safety of AZD7760 administered as a single IV Dose A or Dose B in healthy Japanese adult participants.
Measured: Day 1 to Day 181
Occurrence of Medically-attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)
To evaluate the safety of AZD7760 administered as a single IV Dose A or Dose B in healthy Japanese adult participants.
Measured: Day 1 to Day 361
Secondary outcomes (8)
Maximum observed serum (peak) drug concentration (Cmax)
To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.
Measured: Day 1 to Day 361
Time to reach peak or maximum observed concentration following drug administration (tmax)
To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.
Measured: Day 1 to Day 361
Terminal elimination half-life (t½λz)
To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.
Measured: Day 1 to Day 361
Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast)
To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.
Measured: Day 1 to Day 361
Area under the concentration-time curve from time 0 to infinity (AUCinf)
To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.
Measured: Day 1 to Day 361
Volume of distribution at steady state (Vss)
To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.
Measured: Day 1 to Day 361
Volume of distribution based on the terminal phase (Vz)
To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.
Measured: Day 1 to Day 361
Incidence of Anti-drug antibody (ADA)
To evaluate ADA responses to AZD7760 in serum of healthy Japanese adult participants
Measured: Day 1 to Day 361
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start29 Jun 2026
- Primary completion13 Sep 2027 (estimated)
- Study completion13 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcus Aureus Bloodstream InfectionStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07612813
- Sponsor's protocol ID
- D7480C00003
- Status last verified
- Sep 2026
- First submitted
- 21 May 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. ''Yes", indicates that AZ is accepting requests for IPD, but this does not mean all requests will be approved.