A Phase 1 interventional study of AZD0543 and Placebo in Human Metapneumovirus Infection, sponsored by AstraZeneca. Recruiting at 2 sites in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by AstraZeneca · Phase 1, Interventional, and Prevention
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Among 21 studies in Paramyxoviridae Infections with a site in United States — 2 open to participants now, 2 under way, 1 of them phase 3. Paramyxoviridae Infections · United States.
Among the 21 studies in Paramyxoviridae Infections with a site in United States, this one is the 3rd largest by planned enrollment of the 20 interventional ones that give a count, is the only one that started in 2026, is one of 14 in phase 1, and was the 21st registered.
31 studies on the registry are indexed under Paramyxoviridae Infections; 3 are open to participants now.
Browse Paramyxoviridae Infections studies →2 of the 21 studies in Paramyxoviridae Infections with a site in United States are open now. Recruiting first, the newest first:
Ansun Biopharma, Inc. · Sites in United States, Australia, China and 2 more countries
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 3 Paramyxoviridae Infections studies recruiting now, 2 set no upper age limit and 1 stops at 75 or younger; 1 takes children under 18; 1 takes healthy volunteers.
This study: 18 Years to 55 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
21 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 15 · Phase 2 4 · Phase 3 1
First in 2005; this study’s year is marked. 1 started in 2026.
This study's planned enrollment of 144 is above the median of 60 across 25 interventional studies indexed under Paramyxoviridae Infections.
Median enrollment 51 across the 20 interventional studies, 272 across the 1 observational. Of the 18 that completed or were terminated, 5 (28%) have results posted.
This tab as a report to print or save as PDF → With an account.
12 of 21 have an industry lead sponsor. The 10 most frequent:
AstraZeneca is the lead sponsor of 3,503 studies on the registry; 273 are open to participants now.
Of its 369 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
AstraZeneca has 1 study filed under Paramyxoviridae Infections — fewer than ten, so there is no comparison to draw.
1 of the studies in Paramyxoviridae Infections with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07824622AstraZenecaStudy of Safety and PK of AZD0543 in Healthy Adults | 2027-03-24 |
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Among the 21 studies in Paramyxoviridae Infections with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive a single AZD0543 dose.
Biological: AZD0543
Participants will receive a single dose of placebo.
Other: Placebo
Participants will receive a single AZD0543 dose.
Biological: AZD0543
Participants will receive a single dose of placebo.
Other: Placebo
Participants will receive a single AZD0543 dose.
Biological: AZD0543
Participants will receive a single dose of placebo.
Other: Placebo
Sterile solution for injection or infusion administered as a single IM or IV dose on Day 1.
Volume-matched 0.9% (w/v) sterile saline solution for injection or infusion administered as a single IM or IV dose on Day 1.
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
Time frame: 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
Time frame: 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
Time frame: Through Day 8 post-IMP administration
AEs
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo
Time frame: 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
Time frame: Throughout the study post-IMP administration
AZD0543 serum concentrations over time
To assess the pharmacokinetics (PK) of AZD0543, in serum
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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
To assess anti-drug antibody (ADA) responses to AZD0543 in serum
Time frame: Study Day 1 baseline; Study Day 8, 31, 91, 151, 361
Plan to share: 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.
Supporting information: Study protocol
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Started Aug 2026 (actual). Primary completion is estimated for Mar 2027, 6 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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