Study to Evaluate the Pharmacokinetics (Movement of Drugs Within the Body), Safety and Tolerability of Brazikumab in Healthy Chinese and White Participants

NCT05033431 | Completed Phase 1 FDA Drug

• 1 other identifier: D5271C00004
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Participants

Keywords

Inflammatory bowel disease; Brazikumab; Pharmacokinetics; Crohn's Disease; Ulcerative colitis

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (13)

• Number of participants with Adverse events (AEs) and Serious adverse events (SAEs)

  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

  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

  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

  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

  Day 1 to Day 133

Study Arms (6)

Group 1 [Healthy Chinese Participants]

EXPERIMENTAL

Participants will receive a single intravenous (IV) infusion of brazikumab dose 1 on Day 1.

Drug: Brazikumab

Group 2 [Healthy Chinese Participants]

EXPERIMENTAL

Participants will receive a single IV infusion of brazikumab dose 2 on Day 1.

Drug: Brazikumab

Group 3 [Healthy Chinese Participants]

EXPERIMENTAL

Participants will receive a single subcutaneous (SC) injection of brazikumab dose 3 on Day 1.

Drug: Brazikumab

Group 4 [Healthy Chinese Participants]

EXPERIMENTAL

Participants will receive a single SC injection of brazikumab dose 4 on Day 1.

Drug: Brazikumab

Group 5 [healthy White participants]

EXPERIMENTAL

Participants will receive a single IV infusion of brazikumab dose 2 on Day 1.

Drug: Brazikumab

Group 6 [healthy White participants]

EXPERIMENTAL

Participants will receive a single SC injection of brazikumab dose 4 on Day 1.

Drug: Brazikumab

Interventions

Brazikumab DRUG

Participants will receive IV or SC injection of brazikumab as per the group they are assigned.

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]

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Glendale, California, 91206, United States

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2021
• First Posted: September 2, 2021
• Study Start: October 11, 2021
• Primary Completion: October 12, 2022
• Study Completion: October 12, 2022
• Last Updated: October 27, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Time Frame: 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.
• Access Criteria: 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.

Locations

US (1)