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Monoclonal Antibodies

Brazikumab for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening period (day -28 to day -2) to day 133 and early termination visit
Awards & highlights

Study Summary

This trial is testing a new drug to see how it is tolerated and how it works in the body. It is open to men and women of Chinese and White descent who are healthy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening period (day -28 to day -2) to day 133 and early termination visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening period (day -28 to day -2) to day 133 and early termination visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under serum concentration-time curve from zero to infinity (AUCinf) of brazikumab
Area under the serum concentration-time curve from zero to the last quantifiable concentration (AUClast) of brazikumab
Maximum observed serum (peak) drug concentration (Cmax) of brazikumab
+1 more
Secondary outcome measures
Apparent total body clearance of drug from serum after extravascular administration CL/F of brazikumab (SC only)
Area under the plasma concentration-time curve from time zero to infinity divided by the dose administered (Dose-normalised AUCinf) of brazikumab
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
+10 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: Group 6 [healthy White participants]Experimental Treatment1 Intervention
Participants will receive a single SC injection of brazikumab dose 4 on Day 1.
Group II: Group 5 [healthy White participants]Experimental Treatment1 Intervention
Participants will receive a single IV infusion of brazikumab dose 2 on Day 1.
Group III: Group 4 [Healthy Chinese Participants]Experimental Treatment1 Intervention
Participants will receive a single SC injection of brazikumab dose 4 on Day 1.
Group IV: Group 3 [Healthy Chinese Participants]Experimental Treatment1 Intervention
Participants will receive a single subcutaneous (SC) injection of brazikumab dose 3 on Day 1.
Group V: Group 2 [Healthy Chinese Participants]Experimental Treatment1 Intervention
Participants will receive a single IV infusion of brazikumab dose 2 on Day 1.
Group VI: Group 1 [Healthy Chinese Participants]Experimental Treatment1 Intervention
Participants will receive a single intravenous (IV) infusion of brazikumab dose 1 on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brazikumab
2021
Completed Phase 1
~50

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,267 Previous Clinical Trials
288,606,933 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Study to Evaluate the Pharmacokinetics (Movement of Drugs Within the Body), Safety and Tolerability of Brazikumab in Healthy Chinese and White Participants
2021. "Study to Evaluate the Pharmacokinetics (Movement of Drugs Within the Body), Safety and Tolerability of Brazikumab in Healthy Chinese and White Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05033431.
~14 spots leftby Apr 2025
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