Coronavirus Disease 2019 (COVID-19)Phase 1NCT05437289
A Study to Evaluate the Safety and Tolerability of AZD7442 in Healthy Chinese Adults
A Phase 1 study testing AZD7442 IM and AZD7442 IV in people with Coronavirus Disease 2019 (COVID-19) and Healthy Volunteer, run by AstraZeneca at 2 sites in China.
Trial summary
To evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of AZD7442 in Healthy Chinese Adults. vs. placebo Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Disease 2019 (COVID-19), Healthy Volunteer
- What is being tested?
- AZD7442 IM and AZD7442 IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 2 sitesChina
- Study dates
- 9 Oct 2021to 16 Jan 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Adults 18 to 55 years of age
- Healthy by medical history, physical examination, and baseline safety laboratory tests
- Negative results of both SARS-CoV-2 qRT-PCR and serology tests within 14 days prior to randomisation.
- Contraceptive within 365 days post dosing
Who cannot join
- Medical condition:
- Known hypersensitivity to monoclonal antibody (mAb) or investigational product (IP) component.
- Acute illness including fever on the day prior to or day of dosing.
- Any other significant disease increase the risk to participant study.
- Laboratory related:
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > upper limit of normal (ULN), or alkaline phosphatase (ALP) or TBL (total bilirubin) > 1.5 × ULN
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- Serum creatinine > ULN
- Haemoglobin < lower limit normal (LLN)
- Platelet count < LLN
- White blood cell or neutrophil count outside normal reference ranges
- Other laboratory significantly abnormal in the screening panel that, in the opinion of the investigator, will increase participants risk or might confound analysis of study results.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Phase I Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD7442 in Healthy Chinese Adults
To evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of AZD7442 in Healthy Chinese Adults. vs. placebo
Read the detailed description
A Phase I Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD7442 in healthy Chinese participants 18 to 55 years of age, approximately 60 participants will be randomised in a 4:1 ratio to either AZD7442 or placebo, administered by intramuscular (IM) injection or intravenous (IV) infusion, and approximately 479 days in duration for each participant.
- Being tested
- AZD7442 IM, Placebo IM, AZD7442 IV, Placebo IV
- Keywords
- Coronavirus, COVID-19, AZD7442, Evusheld, LAAB, tixagevimab, AZD8895, cilgavimab, AZD1061
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD7442 IMDrug
Also called AZD7442
In cohort 1, participants will be randomized to receive 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) administered sequentially as direct gluteal IM injections.
Placebo IMDrug
Also called Placebo
In cohort 1, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort administered sequentially as direct gluteal IM injections.
AZD7442 IMDrug
Also called AZD7442
In cohort 2, participants will be randomized to receive 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) administered sequentially as direct gluteal IM injections.
Placebo IMDrug
Also called Placebo
In cohort 2, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort administered sequentially as direct gluteal IM injections.
AZD7442 IVDrug
Also called AZD7442
In cohort 3, participants will be randomized to receive 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) mixed in IV bag co-administered as a single IV infusion.
Placebo IVDrug
Also called Placebo
In cohort 3, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort as a single IV infusion.
AZD7442 IVDrug
Also called Evusheld
In cohort 4, participants will be randomized to receive 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) mixed in IV bag co-administered as a single IV infusion.
Placebo IVDrug
Also called Placebo
In cohort 4, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort as a single IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| 300 mg AZD7442 IM | Experimental | Administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) sequentially by intramuscular (IM) injection. Receives: Drug: AZD7442 IM |
| 300mg placebo IM | Placebo comparator | Administration of placebo with dose match to AZD7442 in the same cohort sequentially by intramuscular (IM) injection. Receives: Drug: Placebo IM |
| 600 mg AZD7442 IM | Experimental | Administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) sequentially by intramuscular (IM) injection. Receives: Drug: AZD7442 IM |
| 600mg placebo IM | Placebo comparator | Administration of placebo with dose match to AZD7442 in the same cohort sequentially by intramuscular (IM) injection. Receives: Drug: Placebo IM |
| 300 mg AZD7442 IV | Experimental | co-administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) by intravenous (IV) infusion. Receives: Drug: AZD7442 IV |
| 300mg placebo IV | Placebo comparator | co-administration of a single dose of placebo in equivalent volume by intravenous (IV) infusion. Receives: Drug: Placebo IV |
| 600 mg AZD7442 IV | Experimental | co-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion. Receives: Drug: AZD7442 IV |
| 600mg placebo IV | Placebo comparator | co-administration of a single dose of placebo in equivalent volume by intravenous (IV) infusion. Receives: Drug: Placebo IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (AEs)
To evaluate the safety and tolerability of AZD7442 administered IM or IV to healthy Chinese participants 18 to 55 years of age.
Measured: From day 1 to approximately 15 months after administration (through Day 451).
Incidence of serious adverse events (SAEs)
To evaluate the safety and tolerability of AZD7442 administered IM or IV to healthy Chinese participants 18 to 55 years of age.
Measured: From day 1 to approximately 15 months after administration (through Day 451).
Incidence of adverse event of special interests (AESIs)
To evaluate the safety and tolerability of AZD7442 administered IM or IV to healthy Chinese participants 18 to 55 years of age.
Measured: From day 1 to approximately 15 months after administration (through Day 451).
Number of participants with abnormal laboratory test results
Measurement of white blood cell (WBC) count, red blood cell (RBC) count.
Measured: From day 1 to approximately 15 months after administration (through Day 451).
Number of participants with abnormal laboratory test results
Measurement of sodium, potassium, urea/blood urea nitrogen (BUN), calcium, phosphate, glucose, c-reactive protein (CRP).
Measured: From day 1 to approximately 15 months after administration (through Day 451).
Number of participants with abnormal Coagulation test results
Measurement of prothrombin time, activated partial thrombin time (aPTT).
Measured: From day 1 to approximately 15 months after administration (through Day 451).
Number of participants with abnormal urinalysis
Measurement of glucose, protein, and blood.
Measured: From day 1 to approximately 15 months after administration (through Day 451).
Number of participants with abnormal ECG readings
Results for PR interval, QRS duration, QT interval, QTcF interval, and RR interval will be analyzed.
Measured: From day 1 to approximately 15 months after administration (through Day 451).
Number of participants with abnormal vital signs
Measurement of systolic blood pressure (mm Hg), diastolic blood pressure (mm Hg).
Measured: From day 1 to approximately 15 months after administration (through Day 451).
Number of participants with abnormal laboratory test results
Measurement of neutrophils absolute count, lymphocytes absolute count, monocytes absolute count, eosinophils absolute count, Platelets, Reticulocytes absolute count.
Measured: From day 1 to approximately 15 months after administration (through Day 451).
Number of participants with abnormal laboratory test results
Measurement of haemoglobin (Hb).
Measured: From day 1 to approximately 15 months after administration (through Day 451).
Number of participants with abnormal laboratory test results
Measurement of haematocrit (HCT).
Measured: From day 1 to approximately 15 months after administration (through Day 451).
Number of participants with abnormal laboratory test results
Measurement of mean corpuscular volume (MCV).
Measured: From day 1 to approximately 15 months after administration (through Day 451).
Number of participants with abnormal laboratory test results
Measurement of mean corpuscular haemoglobin (MCH).
Measured: From day 1 to approximately 15 months after administration (through Day 451).
Number of participants with abnormal laboratory test results
Measurement of alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transpeptidase (GGT), creatine kinase.
Measured: From day 1 to approximately 15 months after administration (through Day 451).
Number of participants with abnormal laboratory test results
Measurement of creatinine, total bilirubin, conjugated bilirubin.
Measured: From day 1 to approximately 15 months after administration (through Day 451).
Number of participants with abnormal laboratory test results
Measurement of albumin.
Measured: From day 1 to approximately 15 months after administration (through Day 451).
Number of participants with abnormal Coagulation test results
Measurement of international normalised ratio (INR).
Measured: From day 1 to approximately 15 months after administration (through Day 451).
Number of participants with abnormal ECG readings
Results for heart rate will be analyzed.
Measured: From day 1 to approximately 15 months after administration (through Day 451).
Number of participants with abnormal vital signs
Measurement of pulse rate (beats per minute), respiratory rate (breaths per minute).
Measured: From day 1 to approximately 15 months after administration (through Day 451).
Number of participants with abnormal vital signs
Measurement of body temperature (in degree Celsius).
Measured: From day 1 to approximately 15 months after administration (through Day 451).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start9 Oct 2021
- Primary completion27 Nov 2021
- Study completion16 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronavirus Disease 2019 (COVID-19)Studies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437289
- Sponsor's protocol ID
- D8850C00007
- Status last verified
- Mar 2023
- First submitted
- 9 Jun 2022
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- 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. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
Publications
Li N, Zhang J, Zhang W, Xu Z, Yao X, He A, Liu S, Ge X, Liu J, Li Y, Chen CC, Zhang H. Safety, Tolerability, and Pharmacokinetics of the Long-Acting SARS-CoV-2-Neutralizing Monoclonal Antibody Combination AZD7442 (Tixagevimab/Cilgavimab) in Healthy Chinese Adults. Clin Pharmacol Drug Dev. 2025 Nov;14(11):836-845. doi: 10.1002/cpdd.1583. Epub 2025 Aug 13.
PubMed 40799036
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD7442 in Healthy Chinese Adults
- ClinicalTrials.gov ID
- NCT05437289
- Acronym / sponsor ID
- D8850C00007
- Keywords
- Coronavirus, COVID-19, AZD7442, Evusheld, LAAB, tixagevimab, AZD8895, cilgavimab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2021 (actual)
- Primary completion
- 27 Nov 2021 (actual)
- Study completion
- 16 Jan 2023 (actual)
- First posted
- 29 Jun 2022 (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.
To evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of AZD7442 in Healthy Chinese Adults. vs. placebo
Detailed description
A Phase I Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD7442 in healthy Chinese participants 18 to 55 years of age, approximately 60 participants will be randomised in a 4:1 ratio to either AZD7442 or placebo, administered by intramuscular (IM) injection or intravenous (IV) infusion, and approximately 479 days in duration for each participant.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 300 mg AZD7442 IM | Experimental | Drug: AZD7442 IMAdministration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) sequentially by intramuscular (IM) injection. |
| 300mg placebo IM | Placebo comparator | Drug: Placebo IMAdministration of placebo with dose match to AZD7442 in the same cohort sequentially by intramuscular (IM) injection. |
| 600 mg AZD7442 IM | Experimental | Drug: AZD7442 IMAdministration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) sequentially by intramuscular (IM) injection. |
| 600mg placebo IM | Placebo comparator | Drug: Placebo IMAdministration of placebo with dose match to AZD7442 in the same cohort sequentially by intramuscular (IM) injection. |
| 300 mg AZD7442 IV | Experimental | Drug: AZD7442 IVco-administration of a single dose of 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) by intravenous (IV) infusion. |
| 300mg placebo IV | Placebo comparator | Drug: Placebo IVco-administration of a single dose of placebo in equivalent volume by intravenous (IV) infusion. |
| 600 mg AZD7442 IV | Experimental | Drug: AZD7442 IVco-administration of a single dose of 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) by intravenous (IV) infusion. |
| 600mg placebo IV | Placebo comparator | Drug: Placebo IVco-administration of a single dose of placebo in equivalent volume by intravenous (IV) infusion. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults 18 to 55 years of age
- Healthy by medical history, physical examination, and baseline safety laboratory tests
- Negative results of both SARS-CoV-2 qRT-PCR and serology tests within 14 days prior to randomisation.
- Contraceptive within 365 days post dosing
Key exclusion criteria (11 listed)
- Medical condition:
- Laboratory related:
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 |
|---|---|---|
| AZD7442 IMAlso: AZD7442In cohort 1, participants will be randomized to receive 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) administered sequentially as direct gluteal IM injections. | Drug | 300 mg AZD7442 IM |
| Placebo IMAlso: PlaceboIn cohort 1, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort administered sequentially as direct gluteal IM injections. | Drug | 300mg placebo IM |
| AZD7442 IMAlso: AZD7442In cohort 2, participants will be randomized to receive 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) administered sequentially as direct gluteal IM injections. | Drug | 600 mg AZD7442 IM |
| Placebo IMAlso: PlaceboIn cohort 2, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort administered sequentially as direct gluteal IM injections. | Drug | 600mg placebo IM |
| AZD7442 IVAlso: AZD7442In cohort 3, participants will be randomized to receive 300 mg AZD7442 (150 mg AZD8895 and 150 mg AZD1061) mixed in IV bag co-administered as a single IV infusion. | Drug | 300 mg AZD7442 IV |
| Placebo IVAlso: PlaceboIn cohort 3, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort as a single IV infusion. | Drug | 300mg placebo IV |
| AZD7442 IVAlso: EvusheldIn cohort 4, participants will be randomized to receive 600 mg AZD7442 (300 mg AZD8895 and 300 mg AZD1061) mixed in IV bag co-administered as a single IV infusion. | Drug | 600 mg AZD7442 IV |
| Placebo IVAlso: PlaceboIn cohort 4, participants will be randomized to receive placebo with dose match to AZD7442 in the same cohort as a single IV infusion. | Drug | 600mg placebo IV |
Primary outcome
Incidence of adverse events (AEs)
Time frame: From day 1 to approximately 15 months after administration (through Day 451).
To evaluate the safety and tolerability of AZD7442 administered IM or IV to healthy Chinese participants 18 to 55 years of age.
Incidence of serious adverse events (SAEs)
Time frame: From day 1 to approximately 15 months after administration (through Day 451).
To evaluate the safety and tolerability of AZD7442 administered IM or IV to healthy Chinese participants 18 to 55 years of age.
Incidence of adverse event of special interests (AESIs)
Time frame: From day 1 to approximately 15 months after administration (through Day 451).
To evaluate the safety and tolerability of AZD7442 administered IM or IV to healthy Chinese participants 18 to 55 years of age.
Number of participants with abnormal laboratory test results
Time frame: From day 1 to approximately 15 months after administration (through Day 451).
Measurement of white blood cell (WBC) count, red blood cell (RBC) count.
Number of participants with abnormal laboratory test results
Time frame: From day 1 to approximately 15 months after administration (through Day 451).
Measurement of sodium, potassium, urea/blood urea nitrogen (BUN), calcium, phosphate, glucose, c-reactive protein (CRP).
Number of participants with abnormal Coagulation test results
Time frame: From day 1 to approximately 15 months after administration (through Day 451).
Measurement of prothrombin time, activated partial thrombin time (aPTT).
Number of participants with abnormal urinalysis
Time frame: From day 1 to approximately 15 months after administration (through Day 451).
Measurement of glucose, protein, and blood.
Number of participants with abnormal ECG readings
Time frame: From day 1 to approximately 15 months after administration (through Day 451).
Results for PR interval, QRS duration, QT interval, QTcF interval, and RR interval will be analyzed.
Number of participants with abnormal vital signs
Time frame: From day 1 to approximately 15 months after administration (through Day 451).
Measurement of systolic blood pressure (mm Hg), diastolic blood pressure (mm Hg).
Number of participants with abnormal laboratory test results
Time frame: From day 1 to approximately 15 months after administration (through Day 451).
Measurement of neutrophils absolute count, lymphocytes absolute count, monocytes absolute count, eosinophils absolute count, Platelets, Reticulocytes absolute count.
Number of participants with abnormal laboratory test results
Time frame: From day 1 to approximately 15 months after administration (through Day 451).
Measurement of haemoglobin (Hb).
Number of participants with abnormal laboratory test results
Time frame: From day 1 to approximately 15 months after administration (through Day 451).
Measurement of haematocrit (HCT).
Number of participants with abnormal laboratory test results
Time frame: From day 1 to approximately 15 months after administration (through Day 451).
Measurement of mean corpuscular volume (MCV).
Number of participants with abnormal laboratory test results
Time frame: From day 1 to approximately 15 months after administration (through Day 451).
Measurement of mean corpuscular haemoglobin (MCH).
Number of participants with abnormal laboratory test results
Time frame: From day 1 to approximately 15 months after administration (through Day 451).
Measurement of alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transpeptidase (GGT), creatine kinase.
Number of participants with abnormal laboratory test results
Time frame: From day 1 to approximately 15 months after administration (through Day 451).
Measurement of creatinine, total bilirubin, conjugated bilirubin.
Number of participants with abnormal laboratory test results
Time frame: From day 1 to approximately 15 months after administration (through Day 451).
Measurement of albumin.
Number of participants with abnormal Coagulation test results
Time frame: From day 1 to approximately 15 months after administration (through Day 451).
Measurement of international normalised ratio (INR).
Number of participants with abnormal ECG readings
Time frame: From day 1 to approximately 15 months after administration (through Day 451).
Results for heart rate will be analyzed.
Number of participants with abnormal vital signs
Time frame: From day 1 to approximately 15 months after administration (through Day 451).
Measurement of pulse rate (beats per minute), respiratory rate (breaths per minute).
Number of participants with abnormal vital signs
Time frame: From day 1 to approximately 15 months after administration (through Day 451).
Measurement of body temperature (in degree Celsius).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Derived from this study: PubMed 40799036Li N, Zhang J, Zhang W, Xu Z, Yao X, He A, Liu S, Ge X, Liu J, Li Y, Chen CC, Zhang H. Safety, Tolerability, and Pharmacokinetics of the Long-Acting SARS-CoV-2-Neutralizing Monoclonal Antibody Combination AZD7442 (Tixagevimab/Cilgavimab) in Healthy Chinese Adults. Clin Pharmacol Drug Dev. 2025 Nov;14(11):836-845. doi: 10.1002/cpdd.1583. Epub 2025 Aug 13.
- 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. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 AZD7442 IM and AZD7442 IV in people with Coronavirus Disease 2019 (COVID-19) and Healthy Volunteer, run by AstraZeneca at 2 sites in China.
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 4 inclusion and 11 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: finished, as of the sponsor's last update on 31 Mar 2023. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (AEs) (time frame: From day 1 to approximately 15 months after administration (through Day 451).). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05437289, which also lists 1 linked publication.
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 31 Mar 2023.