Clinical Trials in the USA / NCT07824622
Recruiting
Phase 1
Study of Safety and PK of AZD0543 in Healthy Adults
NCT07824622 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Human Metapneumovirus Infection
Investigational drug(s) / intervention(s)
AZD0543Placebo
AZD0543: Sterile solution for injection or infusion administered as a single IM or IV dose on Day 1.
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.
Study summary
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.
Eligibility
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
Primary outcome measure(s)
- Immediate AEs within 1 hour of IMP administration — 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 — 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 — Through Day 8 post-IMP administration
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo - AEs — 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 — Throughout the study post-IMP administration
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Los Alamitos | California | Not Yet Recruiting |
| Research Site | South Miami | Florida | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07824622 on ClinicalTrials.gov ↗ ← All trials in the USA