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Brazikumab

Phase 2

Undisclosed | Monoclonal antibody | Other |AstraZeneca PLC|Trials Updated: Oct 27, 2022

Brazikumab development status

Highest phase Phase 2 (NCT03616821)
Phase scored for AZNPhase 1
Registered trials 2 across 1 sponsor since Aug 2018

Brazikumab target and mechanism

Molecular targetIL12B, IL23A
Target classInhibitor
ModalityMonoclonal antibody

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Brazikumab clinical trials

Brazikumab · 1 trial · 1 indication

Phase 1 1
NCT05033431Study to Evaluate the Pharmacokinetics (Movement of Drugs Within the Body), Safety and Tolerability of Brazikumab in Healthy Chinese and White ParticipantsHealthy Participants
COMPLETED48 Analytics
PHASE1COMPLETED
Study to Evaluate the Pharmacokinetics (Movement of Drugs Within the Body), Safety and Tolerability of Brazikumab in Healthy Chinese and White Participants
Healthy ParticipantsUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum observed serum (peak) drug concentration (Cmax) of brazikumab
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
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
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
Day 1 to Day 133

AUC0-28d of brazikumab in healthy Chinese and White participants will be evaluated.

Secondary Endpoints

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
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeOTHER

Treatment Arms

ArmTypeDescription
Group 1 [Healthy Chinese Participants]EXPERIMENTALParticipants will receive a single intravenous (IV) infusion of brazikumab dose 1 on Day 1.
Group 2 [Healthy Chinese Participants]EXPERIMENTALParticipants will receive a single IV infusion of brazikumab dose 2 on Day 1.
Group 3 [Healthy Chinese Participants]EXPERIMENTALParticipants will receive a single subcutaneous (SC) injection of brazikumab dose 3 on Day 1.
Group 4 [Healthy Chinese Participants]EXPERIMENTALParticipants will receive a single SC injection of brazikumab dose 4 on Day 1.
Group 5 [healthy White participants]EXPERIMENTALParticipants will receive a single IV infusion of brazikumab dose 2 on Day 1.
Group 6 [healthy White participants]EXPERIMENTALParticipants will receive a single SC injection of brazikumab dose 4 on Day 1.

Interventions

NameTypeDescription
BrazikumabDRUGParticipants will receive IV or SC injection of brazikumab as per the group they are assigned.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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: * Participant must be of European descent ...

Countries:United States
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Frequently asked questions about Brazikumab

What is Brazikumab?

Brazikumab is an investigational monoclonal antibody developed by AstraZeneca PLC. It is designed to inhibit the IL12B and IL23A targets. The drug has been studied in a Phase 1 clinical trial involving healthy participants, but its specific therapeutic indications have not been disclosed.

What does Brazikumab target?

Brazikumab targets IL12B and IL23A. It is an inhibitor of these molecules, which are involved in immune signaling pathways. By inhibiting IL12B and IL23A, brazikumab may modulate immune responses, though its exact clinical applications are still under investigation.

Who is developing Brazikumab?

Brazikumab is being developed by AstraZeneca PLC, a pharmaceutical company traded on the Nasdaq under the ticker symbol AZN. AstraZeneca is responsible for the research and clinical development of this monoclonal antibody.

What phase is Brazikumab in?

Brazikumab is in Phase 1 clinical development. It has completed one Phase 1 trial, and no active trials are currently listed. As an investigational drug, it has not been approved by the FDA for any indication.

What clinical trials is Brazikumab in?

Brazikumab has been evaluated in a completed Phase 1 trial, NCT05033431, titled "Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Brazikumab in Healthy Chinese and White Participants." This trial enrolled 48 healthy volunteers in the United States.