A Study to Evaluate the Safety and Pharmacokinetics of AZD7760 in Healthy Japanese Adults

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Staphylococcus Aureus Bloodstream Infection
• Intervention / Treatment: Drug: AZD7760; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• Japan
  • Sumida-ku, Japan, 130-0004
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1 (AZD7760 Dose A); Participants receive an IV infusion of AZD7760 Dose A on Day 1.	Drug: AZD7760; Participants will receive AZD7760 via IV infusion.
Experimental: Cohort 2 (AZD7760 Dose B); Participants receive an IV infusion of AZD7760 Dose B on Day 1.	Drug: AZD7760; Participants will receive AZD7760 via IV infusion.
Placebo Comparator: Pooled Placebo; Participants receive an IV infusion of matching placebo on Day 1.	Other: Placebo; Participants will receive matching placebo via IV infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Day 1 to Day 361

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum observed serum (peak) drug concentration (Cmax)	To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.	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.	Day 1 to Day 361
Terminal elimination half-life (t½λz)	To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.	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.	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.	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.	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.	Day 1 to Day 361
Incidence of Anti-drug antibody (ADA)	To evaluate ADA responses to AZD7760 in serum of healthy Japanese adult participants	Day 1 to Day 361

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Parexel

Study record dates

Study Major Dates

• Study Start (Estimated): June 24, 2026
• Primary Completion (Estimated): September 24, 2027
• Study Completion (Estimated): September 24, 2027

Study Registration Dates

• First Submitted: May 21, 2026
• First Submitted That Met QC Criteria: May 21, 2026
• First Posted (Actual): May 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: D7480C00003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No