COVID-19Phase 1NCT04896541
Phase I Double-blind, Placebo-controlled Study of AZD7442
A Phase 1 study testing AZD7442 300 mg IM(male), AZD7442 600 mg IM (male) and AZD7442 300 mg IV (male and female) in people with COVID-19, run by AstraZeneca at 1 site in Japan.
Trial summary
AZD7442 mAbs are being evaluated for administration to prevent or treat COVID-19. This Phase I study will gather important information on the safety and tolerability of AZD7442. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- AZD7442 300 mg IM(male), AZD7442 600 mg IM (male) and AZD7442 300 mg IV (male and female)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteJapan
- Study dates
- 16 Mar 2021to 14 Jun 2022
- 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
- Participants must be Japanese men and women and 18 to 55 years of age inclusive, at the time of signing the informed consent.
- Negative results from both SARS-CoV-2 qRT-PCR and serology tests
- Healthy by medical history, physical examination, and safety laboratory tests, according to the judgement of the investigators
Who cannot join
- Fever above 37.5°C by the time when the participant is randomised; a participant excluded for transient acute illness may be dosed if the illness resolves by the time of randomisation.
- History of infection with SARS or MERS
- Any drug therapy within 7 days prior to Day 1
Trial locations and contacts
1 site 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 Japanese Participants
AZD7442 mAbs are being evaluated for administration to prevent or treat COVID-19. This Phase I study will gather important information on the safety and tolerability of AZD7442.
Read the detailed description
Severe acute respiratory coronavirus 2 is a novel coronavirus that appears to have first emerged in China in November 2019 causing cases of atypical pneumonia. Since then, the COVID-19 pandemic has caused major disruption to healthcare systems with significant socioeconomic impacts. As of 22 December 2020, the virus had spread to all corners of the globe, involving 218 countries/regions with over 78.00 million confirmed cases reported and more than 1.71 million associated deaths. As a response to the ongoing pandemic, AstraZeneca is developing mAbs to the SARS-CoV-2 spike protein. The SARS-CoV-2 spike protein contains the virus's receptor binding domain, which enables the virus to bind to receptors on human cells. By targeting this region of the virus's spike protein, antibodies can block the virus's attachment to human cells, and, therefore, are expected to block infection. AZD7442, a combination of 2 of these mAbs (AZD8895 and AZD1061), is being evaluated for administration to treat or prevent COVID-19. There are currently one ongoing Phase I study and two ongoing Phase III studies with AZD7442, in addition to this treatment study.
Randomization of approximately 40 Japanese participants is planned.
- Conditions
- COVID-19
- Being tested
- AZD7442 300 mg IM(male), AZD7442 600 mg IM (male), AZD7442 300 mg IV (male and female), AZD7442 1000 mg IV (male)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD7442 300 mg IM(male)Biological
Single dose of 300 mg of AZD7442 or saline placebo on Day 1.
AZD7442 600 mg IM (male)Biological
Single dose of 600 mg of AZD7442 or saline placebo on Day 1.
AZD7442 300 mg IV (male and female)Biological
Single dose of 300 mg of AZD7442 or saline placebo on Day 1.
AZD7442 1000 mg IV (male)Biological
Single dose 1000 mg of AZD7442 or saline placebo on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| AZD7442 | Experimental | Single dose (IM injections or IV administration) of AZD7442 or saline placebo on Day 1. Receives: Biological: AZD7442 300 mg IM(male); Biological: AZD7442 600 mg IM (male); Biological: AZD7442 300 mg IV (male and female); Biological: AZD7442 1000 mg IV (male) |
| placebo | Experimental | Single dose (× 2 separate IM injections or IV administration) of AZD7442 or saline placebo on Day 1. Receives: Biological: AZD7442 300 mg IM(male); Biological: AZD7442 600 mg IM (male); Biological: AZD7442 300 mg IV (male and female); Biological: AZD7442 1000 mg IV (male) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event and serious adverse event
To evaluate the safety and tolerability of AZD7442 administered IV or IM_Adverse event and serious adverse event
Measured: Up to Day361
Pharmacokinetics - Serum Concentration
To evaluate the single-dose PK of AZD7442.
Measured: Up to Day361
Pharmacokinetics - Maximum Serum Concentration
To evaluate the single-dose PK of AZD7442.
Measured: Up to Day361
Pharmacokinetics - Time to Maximum Serum Concentration
To evaluate the single-dose PK of AZD7442.
Measured: Up to Day361
Pharmacokinetics - Area under the plasma concentration-time curve to the last measurable time point
To evaluate the single-dose PK of AZD7442.
Measured: Up to Day361
Pharmacokinetics - Area under the plasma concentration-time curve extrapolated to infinity
To evaluate the single-dose PK of AZD7442.
Measured: Up to Day361
Pharmacokinetics - extravascular systemic clearance
To evaluate the single-dose PK of AZD7442.
Measured: Up to 361
Pharmacokinetics -bioavailability
To evaluate the single-dose PK of AZD7442.
Measured: Up to Day361
Pharmacokinetics -extravascular terminal phase volume of distribution
To evaluate the single-dose PK of AZD7442.
Measured: Up to Day361
Secondary outcomes (3)
The serum neutralizing responses against SARS-CoV-2 using Geometric mean fold rise from baseline
Blood samples as neutralizing responses against SARS-CoV-2 in serum will be collected.
Measured: Up to Day361
ADA responses to the AZD7442 in serum.
Blood samples for determination of ADA in serum will be assayed by bioanalytical test sites, using an appropriately validated bioanalytical method.
Measured: Up to Day361
The serum neutralizing responses against SARS-CoV-2 using Geometric mean titre from baseline
Blood samples as neutralizing responses against SARS-CoV-2 in serum will be collected.
Measured: Up to Day361
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start16 Mar 2021
- Primary completion14 Jun 2022
- Study completion14 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04896541
- Sponsor's protocol ID
- D8850C00005
- Status last verified
- Jun 2022
- First submitted
- 26 Feb 2021
- Last updated
- 27 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- 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. Yes, indeed that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Publications
Okada H, Ishikawa K, Itoh Y, Noda Y, Eto T, Pilla Reddy V, Chen CC, Gibbs M, Johnsson E. Safety, tolerability, and pharmacokinetics of half-life extended SARS-CoV-2-neutralizing monoclonal antibodies AZD7442 (tixagevimab/cilgavimab) in healthy Japanese adults. J Infect Chemother. 2023 Nov;29(11):1061-1067. doi: 10.1016/j.jiac.2023.07.014. Epub 2023 Jul 29.
PubMed 37524201Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
PubMed 34473343
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2022. 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 Japanese Participants
- ClinicalTrials.gov ID
- NCT04896541
- Acronym / sponsor ID
- D8850C00005
- Conditions
- COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 14 Jun 2022 (actual)
- Study completion
- 14 Jun 2022 (actual)
- First posted
- 21 May 2021 (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.
AZD7442 mAbs are being evaluated for administration to prevent or treat COVID-19. This Phase I study will gather important information on the safety and tolerability of AZD7442.
Detailed description
Severe acute respiratory coronavirus 2 is a novel coronavirus that appears to have first emerged in China in November 2019 causing cases of atypical pneumonia. Since then, the COVID-19 pandemic has caused major disruption to healthcare systems with significant socioeconomic impacts. As of 22 December 2020, the virus had spread to all corners of the globe, involving 218 countries/regions with over 78.00 million confirmed cases reported and more than 1.71 million associated deaths. As a response to the ongoing pandemic, AstraZeneca is developing mAbs to the SARS-CoV-2 spike protein. The SARS-CoV-2 spike protein contains the virus's receptor binding domain, which enables the virus to bind to receptors on human cells. By targeting this region of the virus's spike protein, antibodies can block the virus's attachment to human cells, and, therefore, are expected to block infection. AZD7442, a combination of 2 of these mAbs (AZD8895 and AZD1061), is being evaluated for administration to treat or prevent COVID-19. There are currently one ongoing Phase I study and two ongoing Phase III studies with AZD7442, in addition to this treatment study.
Randomization of approximately 40 Japanese participants is planned.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AZD7442 | Experimental | Biological: AZD7442 300 mg IM(male), Biological: AZD7442 600 mg IM (male), Biological: AZD7442 300 mg IV (male and female), Biological: AZD7442 1000 mg IV (male)Single dose (IM injections or IV administration) of AZD7442 or saline placebo on Day 1. |
| placebo | Experimental | Biological: AZD7442 300 mg IM(male), Biological: AZD7442 600 mg IM (male), Biological: AZD7442 300 mg IV (male and female), Biological: AZD7442 1000 mg IV (male)Single dose (× 2 separate IM injections or IV administration) of AZD7442 or saline placebo on Day 1. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Participants must be Japanese men and women and 18 to 55 years of age inclusive, at the time of signing the informed consent.
- Negative results from both SARS-CoV-2 qRT-PCR and serology tests
- Healthy by medical history, physical examination, and safety laboratory tests, according to the judgement of the investigators
Key exclusion criteria (3 listed)
- Fever above 37.5°C by the time when the participant is randomised; a participant excluded for transient acute illness may be dosed if the illness resolves by the time of randomisation.
- History of infection with SARS or MERS
- Any drug therapy within 7 days prior to Day 1
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 300 mg IM(male)Single dose of 300 mg of AZD7442 or saline placebo on Day 1. | Biological | AZD7442, placebo |
| AZD7442 600 mg IM (male)Single dose of 600 mg of AZD7442 or saline placebo on Day 1. | Biological | AZD7442, placebo |
| AZD7442 300 mg IV (male and female)Single dose of 300 mg of AZD7442 or saline placebo on Day 1. | Biological | AZD7442, placebo |
| AZD7442 1000 mg IV (male)Single dose 1000 mg of AZD7442 or saline placebo on Day 1. | Biological | AZD7442, placebo |
Primary outcome
Adverse event and serious adverse event
Time frame: Up to Day361
To evaluate the safety and tolerability of AZD7442 administered IV or IM_Adverse event and serious adverse event
Pharmacokinetics - Serum Concentration
Time frame: Up to Day361
To evaluate the single-dose PK of AZD7442.
Pharmacokinetics - Maximum Serum Concentration
Time frame: Up to Day361
To evaluate the single-dose PK of AZD7442.
Pharmacokinetics - Time to Maximum Serum Concentration
Time frame: Up to Day361
To evaluate the single-dose PK of AZD7442.
Pharmacokinetics - Area under the plasma concentration-time curve to the last measurable time point
Time frame: Up to Day361
To evaluate the single-dose PK of AZD7442.
Pharmacokinetics - Area under the plasma concentration-time curve extrapolated to infinity
Time frame: Up to Day361
To evaluate the single-dose PK of AZD7442.
Pharmacokinetics - extravascular systemic clearance
Time frame: Up to 361
To evaluate the single-dose PK of AZD7442.
Pharmacokinetics -bioavailability
Time frame: Up to Day361
To evaluate the single-dose PK of AZD7442.
Pharmacokinetics -extravascular terminal phase volume of distribution
Time frame: Up to Day361
To evaluate the single-dose PK of AZD7442.
3 secondary outcomes
The serum neutralizing responses against SARS-CoV-2 using Geometric mean fold rise from baseline
Time frame: Up to Day361
ADA responses to the AZD7442 in serum.
Time frame: Up to Day361
The serum neutralizing responses against SARS-CoV-2 using Geometric mean titre from baseline
Time frame: Up to Day361
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 27 Jun 2022.
- Derived from this study: PubMed 37524201Okada H, Ishikawa K, Itoh Y, Noda Y, Eto T, Pilla Reddy V, Chen CC, Gibbs M, Johnsson E. Safety, tolerability, and pharmacokinetics of half-life extended SARS-CoV-2-neutralizing monoclonal antibodies AZD7442 (tixagevimab/cilgavimab) in healthy Japanese adults. J Infect Chemother. 2023 Nov;29(11):1061-1067. doi: 10.1016/j.jiac.2023.07.014. Epub 2023 Jul 29.
- Derived from this study: PubMed 34473343Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
- 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. Yes, indeed 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 300 mg IM(male), AZD7442 600 mg IM (male) and AZD7442 300 mg IV (male and female) in people with COVID-19, run by AstraZeneca at 1 site in Japan.
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 3 inclusion and 3 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 27 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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. 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?
Adverse event and serious adverse event (time frame: Up to Day361). The study lists 9 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 NCT04896541, which also lists 2 linked publications.
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 27 Jun 2022.