Healthy ParticipantsPhase 1NCT05033431
Study to Evaluate the Pharmacokinetics (Movement of Drugs Within the Body), Safety and Tolerability of Brazikumab in Healthy Chinese and White Participants
A Phase 1 study testing Brazikumab in people with Healthy Participants, run by AstraZeneca at 1 site in United States.
Trial summary
This is a Phase I, single-centre, open-label, parallel-group, single dose study to evaluate the pharmacokinetics, safety and tolerability of Brazikumab in healthy male and female Chinese participants and healthy male and female White participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Brazikumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2021to 12 Oct 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
- Participant is capable of giving signed and dated informed consent
- Healthy Chinese and White male and female participants aged 18 to 55 years (inclusive), at the time of signing the informed consent
- For White participants only:
- Participant must be of European descent or White Latin American descent by participant report
- For Chinese participants only:
- Participant was born in greater China, including Hong Kong, Macau, and Taiwan
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- Participant has 2 Chinese biological parents and 4 Chinese grandparents as confirmed by interview
- Participant has not been living outside of greater China for more than 10 years at the time of the Screening period
- White male and female participants (Participant must be European descent or White Latin American descent)
- Participant who is overtly healthy as determined by medical evaluation
- Have a body mass index ≥ 18 kg/m^2 and ≤ 30 kg/m^2
- Female participants of childbearing potential must have a negative urine pregnancy test prior to administration of the investigational medicinal product (IMP) and must agree to use a highly effective method of birth control (confirmed by the Investigator) from enrolment throughout the study duration and for at least 18 weeks after last dose of the IMP
- Nonsterilised males who are sexually active with a female partner of childbearing potential should use protocol defined contraception method
Who cannot join
- History of any clinically significant disease or disorder in any body system
- Clinical signs and symptoms consistent with Coronavirus disease 2019 (COVID-19), eg, fever, dry cough, dyspnoea, sore throat, fatigue, or confirmed infection by appropriate laboratory test within the last 4 weeks prior to the Screening period or on admission
- History of alcohol or other substance abuse within the previous 5 years
- Known hypersensitivity to biologic therapy
- Taken any concomitant medications (including over-the-counter medications such as aspirin, acetaminophen, ibuprofen, herbal [including traditional Chinese medicinal products] or dietary supplements and cough syrup, as well as medicines requiring a prescription) within 14 days or 5 half-lives (whichever is longer), or St John's Wort within 30 days before the study drug administration
- Previously taken brazikumab or previously participated in an investigational study of brazikumab (previously known as AMG139 or MEDI2070)
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- Participation in any other clinical investigation using an experimental drug within 30 days or 5 half-lives whichever is longer prior to dosing on Day 1
- For study participants for whom the COVID-19 vaccination is planned, vaccination (all doses) prior to first study drug dose may be advisable. If possible, the first dose of brazikumab should be given at least 30 days after the last dose of vaccine
- Blood or plasma donation within 60 or 30 days, prior to dosing on Day 1
- Any clinically significant abnormal findings in vital signs at the Screening period
- Abnormal electrocardiogram results thought to be clinically significant
- Abnormal and clinically significant results on physical examination, medical history, serum chemistry, haematology, or urinalysis
- Positive test results for anti-human immunodeficiency virus type 1 and type 2 antibodies, hepatitis B surface antigen and hepatitis B core antibody, anti-hepatitis C virus antibodies, human T-lymphotropic virus type 1 and human T-lymphotropic virus type 2 or tuberculosis at the Screening period
- Consumption of alcohol within 72 hours before administration of the study drug
- Positive test results for drug of abuse during the Screening period or on Day -1
- The participant has a condition or is in a situation which, in the Investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study
- Directly or indirectly involved in the conduct and administration of this study as an Investigator, Sub-investigator, study coordinator, or other study staff member; or employee of the Sponsor, or a first-degree family member, significant other, or relative residing with one of the above persons involved directly or indirectly in the study
- Female participant who is breastfeeding
- Evidence of a recent (within 6 months of Day 1) systemic fungal infection, requiring inpatient hospitalisation, and/or antifungal treatment
- Any infection requiring hospitalisation or treatment with IV anti-infectives (including anti-viral treatment) within 4 weeks prior to Screening
- Participant received a Bacille Calmette-Guérin vaccination within 12 months of Day 1 or any other live vaccine less than 4 weeks prior to Day 1 or is planning to receive any such vaccine over the course of the study
- Judgement by the Investigator that the participant should not participate in the study if they have any ongoing or recent (ie, during the Screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements
- Vulnerable participants, eg, kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order
- Participants who cannot communicate reliably with the Investigator
- Detailed inclusion/exclusion criteria are in the study protocol
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of a Single Dose of Brazikumab Administered by IV Infusion and SC Injection in Healthy Chinese and White Participants
This is a Phase I, single-centre, open-label, parallel-group, single dose study to evaluate the pharmacokinetics, safety and tolerability of Brazikumab in healthy male and female Chinese participants and healthy male and female White participants.
- Conditions
- Healthy Participants
- Being tested
- Brazikumab
- Keywords
- Inflammatory bowel disease, Brazikumab, Pharmacokinetics, Crohn's Disease, Ulcerative colitis
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BrazikumabDrug
Participants will receive IV or SC injection of brazikumab as per the group they are assigned.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 [Healthy Chinese Participants] | Experimental | Participants will receive a single intravenous (IV) infusion of brazikumab dose 1 on Day 1. Receives: Drug: Brazikumab |
| Group 2 [Healthy Chinese Participants] | Experimental | Participants will receive a single IV infusion of brazikumab dose 2 on Day 1. Receives: Drug: Brazikumab |
| Group 3 [Healthy Chinese Participants] | Experimental | Participants will receive a single subcutaneous (SC) injection of brazikumab dose 3 on Day 1. Receives: Drug: Brazikumab |
| Group 4 [Healthy Chinese Participants] | Experimental | Participants will receive a single SC injection of brazikumab dose 4 on Day 1. Receives: Drug: Brazikumab |
| Group 5 [healthy White participants] | Experimental | Participants will receive a single IV infusion of brazikumab dose 2 on Day 1. Receives: Drug: Brazikumab |
| Group 6 [healthy White participants] | Experimental | Participants will receive a single SC injection of brazikumab dose 4 on Day 1. Receives: Drug: Brazikumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed serum (peak) drug concentration (Cmax) of brazikumab
Cmax of brazikumab in healthy Chinese and White participants will be evaluated.
Measured: Day 1 to Day 133
Area under serum concentration-time curve from zero to infinity (AUCinf) of brazikumab
AUCinf of brazikumab in healthy Chinese and White participants will be evaluated.
Measured: Day 1 to Day 133
Area under the serum concentration-time curve from zero to the last quantifiable concentration (AUClast) of brazikumab
AUClast of brazikumab in healthy Chinese and White participants will be evaluated.
Measured: Day 1 to Day 133
Partial area under the serum concentration-time curve from time zero to 28 days postdose (AUC0-28d) of brazikumab
AUC0-28d of brazikumab in healthy Chinese and White participants will be evaluated.
Measured: Day 1 to Day 133
Secondary outcomes (13)
Number of participants with Adverse events (AEs) and Serious adverse events (SAEs)
Safety and tolerability of brazikumab in healthy Chinese and White participants will be evaluated.
Measured: From Screening period (Day -28 to Day -2) to Day 133 and Early termination visit
Maximum observed serum (peak) drug concentration divided by the dose administered (Dose-normalised Cmax) of brazikumab
Dose-normalised Cmax of brazikumab in healthy Chinese and White participants will be evaluated.
Measured: Day 1 to Day 133
Area under the plasma concentration-time curve from time zero to infinity divided by the dose administered (Dose-normalised AUCinf) of brazikumab
Dose-normalised AUCinf of brazikumab in healthy Chinese and White participants will be evaluated.
Measured: Day 1 to Day 133
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration divided by the dose administered (Dose-normalised AUClast) of brazikumab
Dose-normalised AUClast of brazikumab in healthy Chinese and White participants will be evaluated.
Measured: Day 1 to Day 133
Partial area under the serum concentration-time curve from time zero to 28 days postdose divided by the dose administered (Dose-normalised AUC0-28d) of brazikumab
Dose-normalised AUC0-28d of brazikumab in healthy Chinese and White participants will be evaluated.
Measured: Day 1 to Day 133
Time to reach peak or maximum observed concentration or response following drug administration (tmax) of brazikumab
tmax of brazikumab in healthy Chinese and White participants will be evaluated.
Measured: Day 1 to Day 133
Terminal elimination rate constant (λz) of brazikumab
λz of brazikumab in healthy Chinese and White participants will be evaluated.
Measured: Day 1 to Day 133
Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz) of brazikumab
t1/2λz of brazikumab in healthy Chinese and White participants will be evaluated.
Measured: Day 1 to Day 133
Total body clearance of drug from serum after intravascular administration (CL) of brazikumab (IV only)
CL of brazikumab in healthy Chinese and White participants will be evaluated.
Measured: Day 1 to Day 133
Volume of distribution following intravascular administration (based on terminal phase [Vz]) of brazikumab (IV only)
Vz of brazikumab in healthy Chinese and White participants will be evaluated.
Measured: Day 1 to Day 133
Apparent total body clearance of drug from serum after extravascular administration CL/F of brazikumab (SC only)
CL/F of brazikumab in healthy Chinese and White participants will be evaluated.
Measured: Day 1 to Day 133
Volume of distribution (apparent) following extravascular administration (based on terminal phase [Vz/F]) of brazikumab (SC only)
Vz/F of brazikumab in healthy Chinese and White participants will be evaluated.
Measured: Day 1 to Day 133
Incidence of positive anti-drug antibodies to brazikumab in serum
Immunogenicity: incidence of brazikumab anti-drug antibodies in serum will be evaluated
Measured: Day 1 to Day 133
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start11 Oct 2021
- Primary completion12 Oct 2022
- Study completion12 Oct 2022
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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033431
- Sponsor's protocol ID
- D5271C00004
- Status last verified
- Oct 2022
- First submitted
- 20 Aug 2021
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- 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. 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 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study to Evaluate the Pharmacokinetics, Safety and Tolerability of a Single Dose of Brazikumab Administered by IV Infusion and SC Injection in Healthy Chinese and White Participants
- ClinicalTrials.gov ID
- NCT05033431
- Acronym / sponsor ID
- D5271C00004
- Conditions
- Healthy Participants
- Keywords
- Inflammatory bowel disease, Brazikumab, Pharmacokinetics, Crohn's Disease, Ulcerative colitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 12 Oct 2022 (actual)
- Study completion
- 12 Oct 2022 (actual)
- First posted
- 2 Sep 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.
This is a Phase I, single-centre, open-label, parallel-group, single dose study to evaluate the pharmacokinetics, safety and tolerability of Brazikumab in healthy male and female Chinese participants and healthy male and female White participants.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 [Healthy Chinese Participants] | Experimental | Drug: BrazikumabParticipants will receive a single intravenous (IV) infusion of brazikumab dose 1 on Day 1. |
| Group 2 [Healthy Chinese Participants] | Experimental | Drug: BrazikumabParticipants will receive a single IV infusion of brazikumab dose 2 on Day 1. |
| Group 3 [Healthy Chinese Participants] | Experimental | Drug: BrazikumabParticipants will receive a single subcutaneous (SC) injection of brazikumab dose 3 on Day 1. |
| Group 4 [Healthy Chinese Participants] | Experimental | Drug: BrazikumabParticipants will receive a single SC injection of brazikumab dose 4 on Day 1. |
| Group 5 [healthy White participants] | Experimental | Drug: BrazikumabParticipants will receive a single IV infusion of brazikumab dose 2 on Day 1. |
| Group 6 [healthy White participants] | Experimental | Drug: BrazikumabParticipants will receive a single SC injection of brazikumab dose 4 on Day 1. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Participant is capable of giving signed and dated informed consent
- Healthy Chinese and White male and female participants aged 18 to 55 years (inclusive), at the time of signing the informed consent
- For White participants only:
- For Chinese participants only:
- White male and female participants (Participant must be European descent or White Latin American descent)
Key exclusion criteria (25 listed)
- History of any clinically significant disease or disorder in any body system
- Clinical signs and symptoms consistent with Coronavirus disease 2019 (COVID-19), eg, fever, dry cough, dyspnoea, sore throat, fatigue, or confirmed infection by appropriate laboratory test within the last 4 weeks prior to the Screening period or on admission
- History of alcohol or other substance abuse within the previous 5 years
- Known hypersensitivity to biologic therapy
- Taken any concomitant medications (including over-the-counter medications such as aspirin, acetaminophen, ibuprofen, herbal [including traditional Chinese medicinal products] or dietary supplements and cough syrup, as well as medicines requiring a prescription) within 14 days or 5 half-lives (whichever is longer), or St John's Wort within 30 days before the study drug administration
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 |
|---|---|---|
| BrazikumabParticipants will receive IV or SC injection of brazikumab as per the group they are assigned. | Drug | Group 1 [Healthy Chinese Participants], Group 2 [Healthy Chinese Participants], Group 3 [Healthy Chinese Participants], Group 4 [Healthy Chinese Participants], Group 5 [healthy White participants], Group 6 [healthy White participants] |
Primary outcome
Maximum observed serum (peak) drug concentration (Cmax) of brazikumab
Time frame: Day 1 to Day 133
Cmax of brazikumab in healthy Chinese and White participants will be evaluated.
Area under serum concentration-time curve from zero to infinity (AUCinf) of brazikumab
Time frame: Day 1 to Day 133
AUCinf of brazikumab in healthy Chinese and White participants will be evaluated.
Area under the serum concentration-time curve from zero to the last quantifiable concentration (AUClast) of brazikumab
Time frame: Day 1 to Day 133
AUClast of brazikumab in healthy Chinese and White participants will be evaluated.
Partial area under the serum concentration-time curve from time zero to 28 days postdose (AUC0-28d) of brazikumab
Time frame: Day 1 to Day 133
AUC0-28d of brazikumab in healthy Chinese and White participants will be evaluated.
13 secondary outcomes
Number of participants with Adverse events (AEs) and Serious adverse events (SAEs)
Time frame: From Screening period (Day -28 to Day -2) to Day 133 and Early termination visit
Maximum observed serum (peak) drug concentration divided by the dose administered (Dose-normalised Cmax) of brazikumab
Time frame: Day 1 to Day 133
Area under the plasma concentration-time curve from time zero to infinity divided by the dose administered (Dose-normalised AUCinf) of brazikumab
Time frame: Day 1 to Day 133
Area under the plasma concentration-time curve from time zero to the last quantifiable concentration divided by the dose administered (Dose-normalised AUClast) of brazikumab
Time frame: Day 1 to Day 133
Partial area under the serum concentration-time curve from time zero to 28 days postdose divided by the dose administered (Dose-normalised AUC0-28d) of brazikumab
Time frame: Day 1 to Day 133
Time to reach peak or maximum observed concentration or response following drug administration (tmax) of brazikumab
Time frame: Day 1 to Day 133
Terminal elimination rate constant (λz) of brazikumab
Time frame: Day 1 to Day 133
Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz) of brazikumab
Time frame: Day 1 to Day 133
Total body clearance of drug from serum after intravascular administration (CL) of brazikumab (IV only)
Time frame: Day 1 to Day 133
Volume of distribution following intravascular administration (based on terminal phase [Vz]) of brazikumab (IV only)
Time frame: Day 1 to Day 133
Apparent total body clearance of drug from serum after extravascular administration CL/F of brazikumab (SC only)
Time frame: Day 1 to Day 133
Volume of distribution (apparent) following extravascular administration (based on terminal phase [Vz/F]) of brazikumab (SC only)
Time frame: Day 1 to Day 133
Incidence of positive anti-drug antibodies to brazikumab in serum
Time frame: Day 1 to Day 133
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 Oct 2022.
- 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 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 Brazikumab in people with Healthy Participants, run by AstraZeneca at 1 site 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 13 inclusion and 25 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 Oct 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 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. 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?
Maximum observed serum (peak) drug concentration (Cmax) of brazikumab (time frame: Day 1 to Day 133). The study lists 4 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 27 Oct 2022.