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Safety Study of AZD0233 in Healthy Adults
Phase 1
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All females must have a negative pregnancy test at the Screening Visit and on admission to the Clinical Unit
Have a body mass index between 18 and 30 kg/m² inclusive and weigh at least 50 kg
Must not have
Known history of primary immunodeficiency (congenital or acquired) or an underlying condition that predisposes to infection
Concomitant immunosuppressive and/or steroid treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 (pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 hours), day 2 (24 hours and 36 hours post-dose) and day 3 (48 hours post-dose)
Summary
"This trial aims to test the safety, side effects, and how the body processes AZD0233 in healthy volunteers after receiving different doses of the medication."
Who is the study for?
Healthy adults, particularly those of Japanese descent with both parents and all grandparents being Japanese. Participants must have a BMI between 18-30 kg/m², weigh at least 50 kg, and suitable veins for blood draws. Women must not be pregnant and men with fertile partners must use contraception. Excludes vegans, those with dietary restrictions or recent minor medical issues that could affect the study.
What is being tested?
The trial is testing AZD0233's safety and how the body processes it after one or more doses in healthy people compared to a placebo (a substance with no therapeutic effect). It involves taking either the drug or placebo to see what happens in their bodies over time.
What are the potential side effects?
While specific side effects are not listed for AZD0233 as it's under investigation, common side effects from clinical trials can include headaches, nausea, fatigue, reactions at the injection site if applicable, and potential allergic reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have taken a pregnancy test and it was negative.
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My BMI is between 18 and 30, and I weigh at least 50 kg.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a condition that makes me more likely to get infections.
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I am currently taking immunosuppressive drugs or steroids.
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I do not have any digestive, liver, or kidney diseases that affect how my body handles medicine.
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I am showing signs and symptoms that could be COVID-19.
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I can communicate clearly with my doctor.
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I have previously been treated with AZD0233.
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I haven't taken drugs like St John's Wort that affect certain enzymes in the last 3 weeks.
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I haven't had a serious infection or fever in the last 14 days.
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I have not had any serious infections in the last 60 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 (pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 hours), day 2 (24 hours and 36 hours post-dose) and day 3 (48 hours post-dose)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 (pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 hours), day 2 (24 hours and 36 hours post-dose) and day 3 (48 hours post-dose)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Secondary study objectives
Accumulation ratio for AUC (Rac AUC) of AZD0233
Accumulation ratio for Cmax (Rac Cmax) of AZD0233
Apparent total body clearance of drug from plasma after extravascular administration (CL/F) of AZD0233
+12 moreTrial Design
11Treatment groups
Experimental Treatment
Placebo Group
Group I: Part B (MAD): Cohort 3B - AZD0233 (dose 8)Experimental Treatment1 Intervention
Healthy participants will receive AZD0233 (dose 8) orally as a multiple ascending dose.
Group II: Part B (MAD): Cohort 2B - AZD0233 (dose 7)Experimental Treatment1 Intervention
Healthy participants will receive AZD0233 (dose 7) orally as a multiple ascending dose.
Group III: Part B (MAD): Cohort 1B - AZD0233 (dose 6)Experimental Treatment1 Intervention
Healthy participants will receive AZD0233 (dose 6) orally as a multiple ascending dose.
Group IV: Part A (SAD): Food Effect (FE) extended Cohort 3AExperimental Treatment1 Intervention
Healthy participants from Cohort 3A will participate in this extended cohort after a washout period of 24 hours.
Group V: Part A (SAD): Cohort 5A - AZD0233 (dose 5)Experimental Treatment1 Intervention
Healthy participants will receive AZD0233 (dose 5) orally as a single ascending dose.
Group VI: Part A (SAD): Cohort 4A - AZD0233 (dose 4)Experimental Treatment1 Intervention
Healthy participants will receive AZD0233 (dose 4) orally as a single ascending dose.
Group VII: Part A (SAD): Cohort 3A - AZD0233 (dose 3)Experimental Treatment1 Intervention
Healthy participants will receive AZD0233 (dose 3) orally as a single ascending dose.
Group VIII: Part A (SAD): Cohort 2A - AZD0233 (dose 2)Experimental Treatment1 Intervention
Healthy participants will receive AZD0233 (dose 2) orally as a single ascending dose.
Group IX: Part A (SAD): Cohort 1A - AZD0233 (dose 1)Experimental Treatment1 Intervention
Healthy participants will receive AZD0233 (dose 1) orally as a single ascending dose.
Group X: Part B (MAD): Placebo cohortPlacebo Group1 Intervention
Healthy participants will receive placebo orally as a multiple ascending dose.
Group XI: Part A (SAD): Placebo cohortPlacebo Group1 Intervention
Healthy participants will receive placebo orally as a single ascending dose.
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
AstraZenecaLead Sponsor
4,427 Previous Clinical Trials
289,164,356 Total Patients Enrolled
ParexelIndustry Sponsor
314 Previous Clinical Trials
96,690 Total Patients Enrolled