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NCT07824622PHASE1RecruitingAccepts Healthy Volunteers

Study of Safety and PK of AZD0543 in Healthy Adults

AstraZeneca

Start Date

8/31/2026

Completion Date

12/20/2027

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.

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.

Eligibility Criteria

Age Range: 18 years to 55 years

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

Interventions

BIOLOGICAL

AZD0543

OTHER

Placebo

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Conditions

Human Metapneumovirus Infection

Locations

Research Site

Los Alamitos, California 90720

United States

Research Site

South Miami, Florida 33143

United States