Healthy ParticipantsPhase 1NCT07222254
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of a Single Ascending Dose of AZD0292 in Healthy Japanese Participants
A Phase 1 study testing AZD0292 in people with Healthy Participants, run by AstraZeneca at 1 site in Japan.
Trial summary
The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics (PK) of single ascending doses of AZD0292 administered via intravenous (IV) infusion in healthy Japanese participants. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- AZD0292
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteJapan
- Study dates
- 12 Dec 2025to 30 Jul 2026
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Japanese participants with suitable veins for cannulation or repeated venipuncture.
- Women of childbearing potential (WOCBP) must have a negative pregnancy test and must not be lactating.
- Participants must agree to use an approved method of highly effective contraception as defined in the protocol.
- Have a body mass index (BMI) between 18 and 32 kg/m2 inclusive and weigh at least 45 kg at screening.
Who cannot join
- History of any clinically important disease or disorder which may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
- History or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- History of malignancy, other than treated non-melanoma skin cancers or locally-treated cervical cancer, in the previous 5 years.
- Any clinically important illness, chronic infections or individuals who are at increased risk of infection.
- History of acquired or inherited immunodeficiency disorders.
- History of severe coronavirus disease 2019 (COVID-19) infection requiring hospitalization within the last 12 months or clinical history compatible with ongoing long COVID-19.
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- Current smokers or those who have smoked or used nicotine products within the previous 6 months prior to screening.
- History of alcohol or drug abuse within the past 2 years.
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the PI or history of hypersensitivity to drugs with a similar chemical structure or class to AZD0292 and excipients contained in AZD0292.
- Known hypersensitivity to antihistamines.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD0292 Following Single Ascending Dose Administration to Healthy Japanese Participants
The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics (PK) of single ascending doses of AZD0292 administered via intravenous (IV) infusion in healthy Japanese participants.
Read the detailed description
This is a Phase I, randomized, double-blind, placebo-controlled, single ascending dose study in healthy Japanese participants to investigate 2 dose levels of AZD0292. Participants will be randomized to receive either AZD0292 or placebo, proceeding with sentinel cohorts.
The study will comprise:
- A Screening Period of maximum 28 days.
- A Treatment Period during which participants will be resident at the site from the day before study intervention administration (Day -1) until at least 24 h post-EOI with study intervention; and discharged on Day 2.
- A Follow-up Period from Day 3 to Day 16.
- An extended Follow-up Period from Day 17 to Day 161.
- Conditions
- Healthy Participants
- Being tested
- AZD0292, Placebo
- Keywords
- Monoclonal antibody
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD0292Drug
Single dose of AZD0292 will be administered as an IV infusion.
PlaceboDrug
Single dose of placebo will be administered as an IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| AZD0292 Dose Level 1 | Experimental | Participants will receive AZD0292 (dose level 1) or matching placebo on Day 1. Receives: Drug: AZD0292; Drug: Placebo |
| AZD0292 Dose Level 2 | Experimental | Participants will receive AZD0292 (dose level 2) or matching placebo on Day 1. Receives: Drug: AZD0292; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events (AEs), serious adverse events (SAEs) and adverse event of special interest (AESI)
To assess the safety and tolerability of AZD0292 following IV administration of single ascending doses to healthy Japanese adult participants.
Measured: Up to Extended Follow-up Period (Day 161)
Secondary outcomes (4)
Maximum observed drug concentration (Cmax)
To characterize the Cmax of AZD0292 following administration of single ascending doses of AZD0292 to healthy Japanese adult participants.
Measured: From Day 1 to Extended Follow-up Period (Day 161)
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
To characterize the AUClast of AZD0292 following administration of single ascending doses of AZD0292 to healthy Japanese adult participants.
Measured: From Day 1 to Extended Follow-up Period (Day 161)
Area under concentration-time curve from time 0 to infinity (AUCinf)
To characterize the AUCinf of AZD0292 following administration of single ascending doses of AZD0292 to healthy Japanese adult participants.
Measured: From Day 1 to Extended Follow-up Period (Day 161)
Number of participants with positive anti-drug antibodies (ADAs) to AZD0292 in serum
To evaluate the ADA responses following administration of single ascending doses of AZD0292 to healthy Japanese adult participants.
Measured: From Day 1 to Extended Follow-up Period (Day 161)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2025
- Study start12 Dec 2025
- Primary completion30 Jul 2026
- Study completion30 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222254
- Sponsor's protocol ID
- D7700C00004
- Status last verified
- Aug 2026
- First submitted
- 28 Oct 2025
- Last updated
- 20 Aug 2026
- 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 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 20 Aug 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, Tolerability, and Pharmacokinetics of AZD0292 Following Single Ascending Dose Administration to Healthy Japanese Participants
- ClinicalTrials.gov ID
- NCT07222254
- Acronym / sponsor ID
- D7700C00004
- Conditions
- Healthy Participants
- Keywords
- Monoclonal antibody
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 29 Oct 2025 (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 the study is to evaluate the safety, tolerability and pharmacokinetics (PK) of single ascending doses of AZD0292 administered via intravenous (IV) infusion in healthy Japanese participants.
Detailed description
This is a Phase I, randomized, double-blind, placebo-controlled, single ascending dose study in healthy Japanese participants to investigate 2 dose levels of AZD0292. Participants will be randomized to receive either AZD0292 or placebo, proceeding with sentinel cohorts.
The study will comprise:
- A Screening Period of maximum 28 days.
- A Treatment Period during which participants will be resident at the site from the day before study intervention administration (Day -1) until at least 24 h post-EOI with study intervention; and discharged on Day 2.
- A Follow-up Period from Day 3 to Day 16.
- An extended Follow-up Period from Day 17 to Day 161.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AZD0292 Dose Level 1 | Experimental | Drug: AZD0292, Drug: PlaceboParticipants will receive AZD0292 (dose level 1) or matching placebo on Day 1. |
| AZD0292 Dose Level 2 | Experimental | Drug: AZD0292, Drug: PlaceboParticipants will receive AZD0292 (dose level 2) or matching placebo on Day 1. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy Japanese participants with suitable veins for cannulation or repeated venipuncture.
- Women of childbearing potential (WOCBP) must have a negative pregnancy test and must not be lactating.
- Participants must agree to use an approved method of highly effective contraception as defined in the protocol.
- Have a body mass index (BMI) between 18 and 32 kg/m2 inclusive and weigh at least 45 kg at screening.
Key exclusion criteria (10 listed)
- History of any clinically important disease or disorder which may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
- History or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- History of malignancy, other than treated non-melanoma skin cancers or locally-treated cervical cancer, in the previous 5 years.
- Any clinically important illness, chronic infections or individuals who are at increased risk of infection.
- History of acquired or inherited immunodeficiency disorders.
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 |
|---|---|---|
| AZD0292Single dose of AZD0292 will be administered as an IV infusion. | Drug | AZD0292 Dose Level 1, AZD0292 Dose Level 2 |
| PlaceboSingle dose of placebo will be administered as an IV infusion. | Drug | AZD0292 Dose Level 1, AZD0292 Dose Level 2 |
Primary outcome
Number of participants with adverse events (AEs), serious adverse events (SAEs) and adverse event of special interest (AESI)
Time frame: Up to Extended Follow-up Period (Day 161)
To assess the safety and tolerability of AZD0292 following IV administration of single ascending doses to healthy Japanese adult participants.
4 secondary outcomes
Maximum observed drug concentration (Cmax)
Time frame: From Day 1 to Extended Follow-up Period (Day 161)
Area under concentration-curve from time 0 to the last quantifiable concentration (AUClast)
Time frame: From Day 1 to Extended Follow-up Period (Day 161)
Area under concentration-time curve from time 0 to infinity (AUCinf)
Time frame: From Day 1 to Extended Follow-up Period (Day 161)
Number of participants with positive anti-drug antibodies (ADAs) to AZD0292 in serum
Time frame: From Day 1 to Extended Follow-up Period (Day 161)
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 20 Aug 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. 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 AZD0292 in people with Healthy Participants, 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 4 inclusion and 10 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 20 Aug 2026. 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?
Number of participants with adverse events (AEs), serious adverse events (SAEs) and adverse event of special interest (AESI) (time frame: Up to Extended Follow-up Period (Day 161)). 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 20 Aug 2026.