Safety Study of AZD0233 in Healthy Adults
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part A (SAD)
Participants receive single ascending doses of AZD0233 or placebo. Includes a food effect study for Cohort 3A.
Follow-up Part A
Participants are monitored for safety and effectiveness after treatment in Part A.
Treatment Part B (MAD)
Participants receive multiple ascending doses of AZD0233 or placebo.
Follow-up Part B
Participants are monitored for safety and effectiveness after treatment in Part B.
Treatment Details
Interventions
- AZD0233
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
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
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
Parexel
Chief Medical Officer since 2023
MD from the Royal College of Surgeons in Ireland