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

NCT07612813 | Recruiting Phase 1

• 1 other identifier: D7480C00003
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Staphylococcus Aureus Bloodstream Infection

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (8)

• Maximum observed serum (peak) drug concentration (Cmax)

  Day 1 to Day 361

• Time to reach peak or maximum observed concentration following drug administration (tmax)

  Day 1 to Day 361

• Terminal elimination half-life (t½λz)

  Day 1 to Day 361

• Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast)

  Day 1 to Day 361

• Area under the concentration-time curve from time 0 to infinity (AUCinf)

  Day 1 to Day 361

Study Arms (3)

Cohort 1 (AZD7760 Dose A)

EXPERIMENTAL

Participants receive an IV infusion of AZD7760 Dose A on Day 1.

Drug: AZD7760

Cohort 2 (AZD7760 Dose B)

EXPERIMENTAL

Participants receive an IV infusion of AZD7760 Dose B on Day 1.

Drug: AZD7760

Pooled Placebo

PLACEBO COMPARATOR

Participants receive an IV infusion of matching placebo on Day 1.

Other: Placebo

Interventions

AZD7760 DRUG

Participants will receive AZD7760 via IV infusion.

Cohort 1 (AZD7760 Dose A); Cohort 2 (AZD7760 Dose B)

Placebo OTHER

Participants will receive matching placebo via IV infusion.

Pooled Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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:
• mL whole blood donation within 12 weeks (males) or 16 weeks (females) prior to study drug administration.
• mL whole blood donation within 4 weeks prior to study drug administration.

Sponsors & Collaborators

• AstraZeneca: lead
• Parexel: collaborator

Study Sites (1)

Research Site

Sumida-ku, 130-0004, Japan

RECRUITING

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 29, 2026
• Study Start: June 29, 2026
• Primary Completion (Estimated): September 13, 2027
• Study Completion (Estimated): September 13, 2027
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• 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.
• 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.

Locations

JP (1)