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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 [Healthy Chinese Participants] | Experimental | Participants will receive a single intravenous (IV) infusion of brazikumab dose 1 on Day 1. |
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| Group 2 [Healthy Chinese Participants] | Experimental | Participants will receive a single IV infusion of brazikumab dose 2 on Day 1. |
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| Group 3 [Healthy Chinese Participants] | Experimental | Participants will receive a single subcutaneous (SC) injection of brazikumab dose 3 on Day 1. |
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| Group 4 [Healthy Chinese Participants] | Experimental | Participants will receive a single SC injection of brazikumab dose 4 on Day 1. |
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| Group 5 [healthy White participants] | Experimental | Participants will receive a single IV infusion of brazikumab dose 2 on Day 1. |
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| Group 6 [healthy White participants] |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brazikumab | Drug | Participants will receive IV or SC injection of brazikumab as per the group they are assigned. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed serum (peak) drug concentration (Cmax) of brazikumab | Cmax of brazikumab in healthy Chinese and White participants will be evaluated. | 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. | 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. | 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. | Day 1 to Day 133 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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Inclusion Criteria:
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)
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
Exclusion Criteria:
Detailed inclusion/exclusion criteria are in the study protocol
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Glendale | California | 91206 | United States |
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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AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at:
https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.
When a request has been approved AstraZeneca will provide access to the de-identified individual patientlevel data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at:
https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure.
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Participants will receive a single SC injection of brazikumab dose 4 on Day 1. |
|
Dose-normalised Cmax of brazikumab in healthy Chinese and White participants will be evaluated. |
| 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. | 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. | 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. | 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. | Day 1 to Day 133 |
| Terminal elimination rate constant (λz) of brazikumab | λz of brazikumab in healthy Chinese and White participants will be evaluated. | 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. | 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. | 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. | 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. | 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. | 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 | Day 1 to Day 133 |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
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