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Study of Safety and PK of AZD0543 in Healthy Adults
RecruitingPhase 1Healthy volunteers welcome
A Phase I, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Pharmacokinetics of AZD0543 in Healthy Adults
Who can join
Ages 18 to 55 · All sexes · Healthy volunteers welcome
Full eligibility 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
About the study
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.
What is being tested
- AZD0543 (biological)
- Placebo (other)
Sponsor: AstraZeneca · Participants: 144 · Started: Aug 31, 2026
Contact the study team
- AstraZeneca Clinical Study Information Center · Phone: 1-877-240-9479
Official record on ClinicalTrials.gov — NCT07824622
Locations in the U.S.
| California | Research Site, Los Alamitos (Not yet recruiting) |
| Florida | Research Site, South Miami |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.