Human Metapneumovirus InfectionPhase 1NCT07824622
Study of Safety and PK of AZD0543 in Healthy Adults
A Phase 1 study testing AZD0543 in people with Human Metapneumovirus Infection, run by AstraZeneca at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Human Metapneumovirus Infection
- What is being tested?
- AZD0543
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Aug 2026to 20 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
United States2 sites, 2 recruiting
- Not yet recruiting
Research Site
Los Alamitos, California, 90720
- Recruiting
Research Site
South Miami, Florida, 33143
About this study
Official title: A Phase I, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Pharmacokinetics of AZD0543 in Healthy Adults
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.
Read the 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.
- Conditions
- Human Metapneumovirus Infection
- Being tested
- AZD0543, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD0543Biological
Sterile solution for injection or infusion administered as a single IM or IV dose on Day 1.
PlaceboOther
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 group | Role | What they receive |
|---|---|---|
| Cohort 1: Low Dose AZD0543 | Experimental | Participants will receive a single AZD0543 dose. Receives: Biological: AZD0543 |
| Cohort 1: Placebo | Placebo comparator | Participants will receive a single dose of placebo. Receives: Other: Placebo |
| Cohort 2: Medium Dose AZD0543 | Experimental | Participants will receive a single AZD0543 dose. Receives: Biological: AZD0543 |
| Cohort 2: Placebo | Placebo comparator | Participants will receive a single dose of placebo. Receives: Other: Placebo |
| Cohort 3: High Dose AZD0543 | Experimental | Participants will receive a single AZD0543 dose. Receives: Biological: AZD0543 |
| Cohort 3: Placebo | Placebo comparator | Participants will receive a single dose of placebo. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate AEs within 1 hour of IMP administration
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo
Measured: Within 1 hour of IMP administration
Injection/infusion-related reactions
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo
Measured: Within 24 hours of IMP administration
Injection/infusion site reactions
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo
Measured: Through Day 8 post-IMP administration
AEs
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo
Measured: Through Day 91 post-IMP administration
SAEs, MAAEs, and AESIs
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo
Measured: Throughout the study post-IMP administration
Secondary outcomes (10)
AZD0543 serum concentrations over time
To assess the pharmacokinetics (PK) of AZD0543, in serum
Measured: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
AZD0543 Cmax
To assess the pharmacokinetics (PK) of AZD0543, in serum
Measured: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
AZD0543 Tmax
To assess the pharmacokinetics (PK) of AZD0543, in serum
Measured: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
AZD0543 t½λz
To assess the pharmacokinetics (PK) of AZD0543, in serum
Measured: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
AZD0543 AUClast
To assess the pharmacokinetics (PK) of AZD0543, in serum
Measured: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
AZD0543 AUCinf
To assess the pharmacokinetics (PK) of AZD0543, in serum
Measured: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
AZD0543 CL
To assess the pharmacokinetics (PK) of AZD0543, in serum
Measured: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
AZD0543 Vss
To assess the pharmacokinetics (PK) of AZD0543, in serum
Measured: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
AZD0543 Vz
To assess the pharmacokinetics (PK) of AZD0543, in serum
Measured: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
Incidence of ADA; magnitude of ADA response
To assess anti-drug antibody (ADA) responses to AZD0543 in serum
Measured: Study Day 1 baseline; Study Day 8, 31, 91, 151, 361
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start31 Aug 2026
- Primary completion24 Mar 2027 (estimated)
- Study completion20 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Metapneumovirus InfectionStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824622
- Sponsor's protocol ID
- D9190C00002
- Status last verified
- Sep 2026
- First submitted
- 28 Aug 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Pharmacokinetics of AZD0543 in Healthy Adults
- ClinicalTrials.gov ID
- NCT07824622
- Acronym / sponsor ID
- D9190C00002
- Conditions
- Human Metapneumovirus Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2026 (actual)
- Primary completion
- 24 Mar 2027 (estimated)
- Study completion
- 20 Dec 2027 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Low Dose AZD0543 | Experimental | Biological: AZD0543Participants will receive a single AZD0543 dose. |
| Cohort 1: Placebo | Placebo comparator | Other: PlaceboParticipants will receive a single dose of placebo. |
| Cohort 2: Medium Dose AZD0543 | Experimental | Biological: AZD0543Participants will receive a single AZD0543 dose. |
| Cohort 2: Placebo | Placebo comparator | Other: PlaceboParticipants will receive a single dose of placebo. |
| Cohort 3: High Dose AZD0543 | Experimental | Biological: AZD0543Participants will receive a single AZD0543 dose. |
| Cohort 3: Placebo | Placebo comparator | Other: PlaceboParticipants will receive a single dose of placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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 (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD0543Sterile solution for injection or infusion administered as a single IM or IV dose on Day 1. | Biological | Cohort 1: Low Dose AZD0543, Cohort 2: Medium Dose AZD0543, Cohort 3: High Dose AZD0543 |
| PlaceboVolume-matched 0.9% (w/v) sterile saline solution for injection or infusion administered as a single IM or IV dose on Day 1. | Other | Cohort 1: Placebo, Cohort 2: Placebo, Cohort 3: Placebo |
Primary outcome
Immediate AEs within 1 hour of IMP administration
Time frame: 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
Time frame: 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
Time frame: Through Day 8 post-IMP administration
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo
AEs
Time frame: 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
Time frame: Throughout the study post-IMP administration
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo
10 secondary outcomes
AZD0543 serum concentrations over time
Time frame: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
AZD0543 Cmax
Time frame: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
AZD0543 Tmax
Time frame: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
AZD0543 t½λz
Time frame: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
AZD0543 AUClast
Time frame: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
AZD0543 AUCinf
Time frame: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
AZD0543 CL
Time frame: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
AZD0543 Vss
Time frame: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
AZD0543 Vz
Time frame: Study Day 1 baseline/post-dose; Study Day 2, 4, 8, 31, 91, 151, 271, 361
Incidence of ADA; magnitude of ADA response
Time frame: Study Day 1 baseline; Study Day 8, 31, 91, 151, 361
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
AstraZeneca Clinical Study Information Center contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD0543 in people with Human Metapneumovirus Infection, run by AstraZeneca at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate AEs within 1 hour of IMP administration (time frame: Within 1 hour of IMP administration). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.