Study of Safety and PK of AZD0543 in Healthy Adults

A Phase I, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Pharmacokinetics of AZD0543 in Healthy Adults

The purpose of this study is to assess the safety and PK of AZD0543 compared to placebo in healthy adults 18 to 55 years of age. AZD0543 or placebo will be administered as single IM or IV dose. The study duration will be approximately 12 months for each participant following administration of IMP.

Study Overview

• Status: Recruiting
• Conditions: Human Metapneumovirus Infection
• Intervention / Treatment: Biological: AZD0543; Other: Placebo

Detailed Description

A phase 1, randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety, tolerability and pharmacokinetics of AZD0543 in healthy adults 18-55 years of age. 144 participants will be randomized to receive either one of 3 dose levels of AZD0543 or a placebo comparator of the same volume. AZD0543 or placebo will be administered as a single dose on Day 1 via intramuscular (IM) injection or intravenous (IV) infusion. Participants will be followed for approximately 1 year.

• Study Type: Interventional
• Enrollment (Estimated): 144
• 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

• United States
  • California
    • Los Alamitos, California, United States, 90720
      • Not yet recruiting
      • Research Site
  • Florida
    • South Miami, Florida, United States, 33143
      • Recruiting
      • Research Site

Participation Criteria

Eligibility Criteria

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

Description

Key Inclusion Criteria:

• Age 18 to 55 years
• Body weight ≥ 45 kg and ≤ 110 kg and BMI within the range ≥ 18.0 kg/m2 to ≤ 30 kg/m2

Key Exclusion Criteria:

• Hypersensitivity to IMP/components
• Severe adverse reaction/hypersensitivity to other mAbs
• Acute fever/illness/infection within 3 days of planned dosing
• Clinically important illness/procedure/trauma within 4 weeks of IMP administration
• Active infection with Hepatitis B/C
• Clinically significant bleeding disorders
• Known/suspected immune deficiency/suppression
• Receipt of blood products/immunoglobulins or immunosuppressive therapies within 6 months prior to screening (immunosuppressive medications/therapies include glucocorticoids exceeding 2 weeks of prednisone (or equivalent) 20mg daily or every other day)
• Malignancy within previous 5 years; except treated non-melanoma skin cancers and locally treated cervical cancer
• Receipt of any licensed/investigational hMPV vaccine, other therapies and procedures as applicable; participation in other clinical studies
• Screening Abnormalities: clinically significant ECG, positive drug panel, Hgb/platelets/WBC outside of reference; all SCr/AST/ALT > 1.5X ULN
• Women who are pregnant, lactating, or of childbearing potential and not using a highly effective birth control method

Study Plan

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: Low Dose AZD0543; Participants will receive a single AZD0543 dose.	Biological: AZD0543; Sterile solution for injection or infusion administered as a single IM or IV dose on Day 1.
Placebo Comparator: Cohort 1: Placebo; Participants will receive a single dose of placebo.	Other: Placebo; Volume-matched 0.9% (w/v) sterile saline solution for injection or infusion administered as a single IM or IV dose on Day 1.
Experimental: Cohort 2: Medium Dose AZD0543; Participants will receive a single AZD0543 dose.	Biological: AZD0543; Sterile solution for injection or infusion administered as a single IM or IV dose on Day 1.
Placebo Comparator: Cohort 2: Placebo; Participants will receive a single dose of placebo.	Other: Placebo; Volume-matched 0.9% (w/v) sterile saline solution for injection or infusion administered as a single IM or IV dose on Day 1.
Experimental: Cohort 3: High Dose AZD0543; Participants will receive a single AZD0543 dose.	Biological: AZD0543; Sterile solution for injection or infusion administered as a single IM or IV dose on Day 1.
Placebo Comparator: Cohort 3: Placebo; Participants will receive a single dose of placebo.	Other: Placebo; Volume-matched 0.9% (w/v) sterile saline solution for injection or infusion administered as a single IM or IV dose on Day 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immediate AEs within 1 hour of IMP administration	To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo	Within 1 hour of IMP administration
Injection/infusion-related reactions	To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo	Within 24 hours of IMP administration
Injection/infusion site reactions	To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo	Through Day 8 post-IMP administration
AEs	To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo	Through Day 91 post-IMP administration
SAEs, MAAEs, and AESIs	To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo	Throughout the study post-IMP administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AZD0543 serum concentrations over time	To assess the pharmacokinetics (PK) of AZD0543, in serum	Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
AZD0543 Cmax	To assess the pharmacokinetics (PK) of AZD0543, in serum	Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
AZD0543 Tmax	To assess the pharmacokinetics (PK) of AZD0543, in serum	Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
AZD0543 t½λz	To assess the pharmacokinetics (PK) of AZD0543, in serum	Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
AZD0543 AUClast	To assess the pharmacokinetics (PK) of AZD0543, in serum	Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
AZD0543 AUCinf	To assess the pharmacokinetics (PK) of AZD0543, in serum	Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
AZD0543 CL	To assess the pharmacokinetics (PK) of AZD0543, in serum	Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
AZD0543 Vss	To assess the pharmacokinetics (PK) of AZD0543, in serum	Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
AZD0543 Vz	To assess the pharmacokinetics (PK) of AZD0543, in serum	Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
Incidence of ADA; magnitude of ADA response	To assess anti-drug antibody (ADA) responses to AZD0543 in serum	Study Day 1 baseline; Study Day 8, 31, 91, 151, 361

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2026
• Primary Completion (Estimated): March 24, 2027
• Study Completion (Estimated): December 20, 2027

Study Registration Dates

• First Submitted: August 28, 2026
• First Submitted That Met QC Criteria: September 15, 2026
• First Posted (Actual): September 17, 2026

Study Record Updates

• Last Update Posted (Actual): September 17, 2026
• Last Update Submitted That Met QC Criteria: September 15, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: D9190C00002

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 are accepting requests for IPD, but this does not mean all requests will be shared.

• 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 rerefer 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. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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