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Brazikumab

Phase 1

Healthy Participants | Small molecule | Other |AstraZeneca PLC|Last Updated: Oct 27, 2022

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment48
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05033431Study to Evaluate the Pharmacokinetics (Movement of Drugs Within the Body), Safety and Tolerability of Brazikumab in Healthy Chinese and White ParticipantsPHASE1 COMPLETED 48 — — Oct 11, 2021Oct 12, 2022Oct 27, 20221 United States
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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 — 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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