AZD2389 Safety and Pharmacokinetics in Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, AZD2389, to assess its safety and how the body processes it. The study administers doses of AZD2389 or a placebo (a pill with no active drug) to healthy participants to identify any side effects and understand the drug's behavior in the body. It suits healthy individuals, particularly those of Japanese or Chinese descent, with no recent serious health issues or history of drug or alcohol abuse. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it excludes those with a history of using anti-platelets or anti-coagulants in the past 3 months. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that AZD2389 has undergone safety testing in healthy individuals through several studies. These studies examined how participants managed both single and multiple doses. Most participants tolerated the doses well. Common side effects were mild, such as headaches or dizziness, which are typical with many medications.
One study tested AZD2389 in combination with other drugs to assess interactions, aiding researchers in understanding its safety profile.
As this trial is in the early stages, it emphasizes ensuring the treatment's safety. While past studies provide some information, ongoing research continues to evaluate its safety and effectiveness. Prospective participants should know that researchers closely monitor responses to the treatment.12345Why do researchers think this study treatment might be promising?
Researchers are excited about AZD2389 because it offers a novel approach to treatment with its unique mechanism of action. Unlike current options that typically target common pathways, AZD2389 works by engaging a new biological target, potentially offering a more effective and precise intervention. This could lead to faster results and improved outcomes for patients, distinguishing it from existing therapies. Additionally, AZD2389 is administered orally, which is often more convenient and preferable for patients compared to other methods like injections.
What evidence suggests that this trial's treatments could be effective?
Research shows that this trial is studying AZD2389 to understand its safety and how it functions in the body. Participants in various treatment arms will receive either single or multiple doses of AZD2389, while others will receive a placebo. Scientists are examining how the drug is absorbed, distributed, metabolized, and excreted, as well as its effects on the body. Previous studies have shown that healthy participants can safely take the drug in both single and multiple doses. Although no direct evidence yet supports its effectiveness for a specific condition, these early findings are important to ensure AZD2389 can be safely tested further. This basic research is crucial for understanding how the drug might help treat diseases in the future.12367
Are You a Good Fit for This Trial?
Healthy adults with a BMI of 18-32 and weight over 50 kg can join. Women must not be able to bear children, and men must use contraception. Participants should have good veins for blood draws, no serious health issues or drug abuse history, not smoke or drink excessively, and avoid certain medications before the trial. Specific groups include Japanese or Chinese descent individuals.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 AZD2389 or placebo
Treatment Part B (MAD)
Participants receive multiple ascending doses of AZD2389 or placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AZD2389
- Placebo
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