NCT07824622 · AstraZeneca
Study of Safety and PK of AZD0543 in Healthy Adults
What this study is about
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.
View original scientific description
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.
Interventions
BIOLOGICAL
AZD0543
Sterile solution for injection or infusion administered as a single IM or IV dose on Day 1.
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.
Primary outcome measures
Immediate AEs within 1 hour of IMP administration
Time frame: Within 1 hour of IMP administration
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo
Injection/infusion-related reactions
Time frame: Within 24 hours of IMP administration
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo
Injection/infusion site reactions
Time frame: Through Day 8 post-IMP administration
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo
AEs
Time frame: Through Day 91 post-IMP administration
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo
SAEs, MAAEs, and AESIs
Time frame: Throughout the study post-IMP administration
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Los Alamitos, California
- South Miami, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 17, 2026 · Source of record for eligibility and locations