88 Participants Needed

Safety Study of AZD0233 in Healthy Adults

AC
Overseen ByAstraZeneca Clinical Study Information Center

Trial Summary

Will I have to stop taking my current medications?

Yes, participants must stop taking any prescribed or nonprescribed medications, including antacids, analgesics (except paracetamol/acetaminophen), herbal remedies, and mega dose vitamins and minerals, during the 2 weeks before the study starts. Hormone replacement therapy is allowed for female participants.

What is the purpose of this trial?

The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of AZD0233 following single and multiple ascending dose (SAD and MAD) administration in healthy participants.

Eligibility Criteria

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.

Inclusion Criteria

For the healthy Japanese sub-Cohorts: healthy Japanese participants (e.g., natives of Japan or Japanese Americans) are defined as having both parents and 4 grandparents who are Japanese. This includes healthy second and third generation participants of Japanese descent whose parents or grandparents are living in a country other than Japan
I have veins suitable for repeated needle insertions.
I have taken a pregnancy test and it was negative.
See 3 more

Exclusion Criteria

Participants who are vegans or have medical dietary restrictions
Judgment by the investigator that the participant should not participate in the study if they have any ongoing or recent (ie, during the Screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements
Vulnerable participants, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order
See 21 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

26 days

Treatment Part A (SAD)

Participants receive single ascending doses of AZD0233 or placebo. Includes a food effect study for Cohort 3A.

7 days
Inpatient stay from Day -1 to Day 6

Follow-up Part A

Participants are monitored for safety and effectiveness after treatment in Part A.

7 days
1 visit on Day 8 or Day 10

Treatment Part B (MAD)

Participants receive multiple ascending doses of AZD0233 or placebo.

14 days
Inpatient stay from Day -1 to Day 13

Follow-up Part B

Participants are monitored for safety and effectiveness after treatment in Part B.

7 days
1 visit on Day 17

Treatment Details

Interventions

  • AZD0233
Trial Overview 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.
Participant Groups
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 Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Parexel

Industry Sponsor

Trials
322
Recruited
137,000+
Peyton Howell profile image

Peyton Howell

Parexel

Chief Executive Officer

Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois

Dr. Austin Smith profile image

Dr. Austin Smith

Parexel

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland

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