Recruiting
Phase 1

AZD0543

Sponsor:

AstraZeneca

Code:

NCT07824622

Conditions

Human Metapneumovirus Infection

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

AZD0543

Placebo

Study Details

Brief 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.

Conditions

Human Metapneumovirus Infection

Study ID

NCT07824622

Start date

Aug 31, 2026

Status verified date

Sep, 2026

Completion date

Dec 20, 2027

Anticipated

Primary completion date

Mar 24, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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

Study Design

Enrollment

144 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Cohort 1: Low Dose AZD0543

Participants will receive a single AZD0543 dose.

placebo comparator: Cohort 1: Placebo

Participants will receive a single dose of placebo.

experimental: Cohort 2: Medium Dose AZD0543

Participants will receive a single AZD0543 dose.

placebo comparator: Cohort 2: Placebo

Participants will receive a single dose of placebo.

experimental: Cohort 3: High Dose AZD0543

Participants will receive a single AZD0543 dose.

placebo comparator: Cohort 3: Placebo

Participants will receive a single dose of placebo.

Interventions

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.

Primary outcome measure

  • Immediate AEs within 1 hour of IMP administration [ Time Frame: Within 1 hour of IMP administration ]
  • Injection/infusion-related reactions [ Time Frame: Within 24 hours of IMP administration ]
  • Injection/infusion site reactions [ Time Frame: Through Day 8 post-IMP administration ]
  • AEs [ Time Frame: Through Day 91 post-IMP administration ]
  • SAEs, MAAEs, and AESIs [ Time Frame: Throughout the study post-IMP administration ]

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

1-877-240-9479information.center@astrazeneca.com

Locations

Research Site

Recruiting

South Miami, Florida, United States, 33143

More Information

Sponsor

AstraZeneca

Last update posted

Sep 17, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-09-17.