AZD0543 safety and PK in healthy adults
Official title: A Phase I, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Pharmacokinetics of AZD0543 in Healthy Adults
Run by AstraZeneca · NCT07824622 · Data updated 2026-11-12
This study tests whether AZD0543 is safe and how it behaves in the body compared with a placebo in healthy adults age 18–55.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Enrollment | 144 (estimated) |
| Sponsor | AstraZeneca Industry-sponsored |
| Drugs / interventions | prednisone |
| Locations | 2 sites (Los Alamitos, California and 1 other locations) |
| Status | Recruiting |
| Started | August 31, 2026 |
| Main results expected | March 24, 2027 |
| Study ends | December 20, 2027 |
| Registry record updated | November 9, 2026 |
| Trial ID | NCT07824622 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults 18–55 years old, weighing 45–110 kg with BMI 18.0–30.0, and without contraindicating illnesses or recent immune-altering therapies.
✕Probably not a fit
Participants who do not receive an active dose or who have safety concerns may not experience direct benefit from the study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a phase 1, randomized, double-blind, placebo-controlled, dose-escalation study. It will evaluate safety, tolerability, and pharmacokinetics of AZD0543 given as a single IM or IV dose to 144 healthy participants aged 18–55. Participants are assigned to one of three AZD0543 dose levels or placebo and followed for about one year after dosing. The trial will identify doses that are safe and how the drug is processed in the body, informing future studies for human metapneumovirus infection.
Why it matters
Potential benefit: If successful, AZD0543 could advance understanding of its safety profile and pharmacokinetics, informing future development.
How similar studies have gone: Phase 1 studies in healthy adults often establish safety and PK; this study follows that established approach and has precedent for dose-escalation designs.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Research Site
Los Alamitos, California, United States Recruiting -
Research Site
South Miami, Florida, United States Recruiting
Study contacts
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.