Safety Study of AZD0233 in Healthy Adults
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called AZD0233 (also known as ION449) to assess its safety and behavior in the body at various doses. Participants will either receive the actual treatment or a placebo (a non-active substance). The trial targets healthy individuals with good veins for blood draws who meet specific weight and BMI criteria. It is suitable for those without major medical conditions or a history of drug or alcohol abuse. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the unique opportunity to be among the first to receive it.
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.
Is there any evidence suggesting that AZD0233 is likely to be safe for humans?
Research has shown that AZD0233 has been studied for its safety in healthy adults. The studies found that AZD0233 is generally well-tolerated in both single and multiple doses. Participants reported few side effects, and those that did occur were mild. This suggests AZD0233 could be safe for humans at the doses tested so far.
However, these studies remain in the early stages. While the initial results are promising, more research is needed to fully understand the safety of AZD0233. People interested in participating should consider these findings and any potential risks when deciding whether to join clinical trials.12345Why do researchers think this study treatment might be promising?
Researchers are excited about AZD0233 because it offers a potentially novel approach to treatment with its unique mechanism of action. Unlike many traditional treatments that rely on well-established pathways, AZD0233 may target different pathways or involve a new active ingredient, setting it apart from the current standard of care. This could lead to improved outcomes or reduced side effects, making it a promising candidate for future therapeutic options.
What evidence suggests that AZD0233 could be effective?
Research shows that AZD0233, also called ION449, may help lower cholesterol levels. In an earlier study, a similar drug reduced "bad" cholesterol (LDL-C) by 62.3%, a very positive result. Most participants in the studies did not experience serious side effects, indicating the drug was generally well tolerated. This trial will assess the safety of AZD0233 at different doses, with some participants receiving varying doses of AZD0233 and others receiving a placebo. While these results are promising, more research is needed to determine its effectiveness and safety at different doses.12678
Are You a Good Fit for This Trial?
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 for a Trial Participant
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.
What Are the Treatments Tested in This Trial?
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