AZD4144 Safety Study in Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand the safety and effects of a new treatment called AZD4144. Researchers assess how the body processes AZD4144 and whether it causes any side effects, comparing it to a placebo (a harmless pill resembling the real treatment). They also examine how AZD4144 interacts with other drugs like rosuvastatin and furosemide. The trial suits healthy individuals, particularly those of Japanese or Chinese descent, who have not lived outside their country for more than ten years. Individuals with significant health issues or allergies may not be suitable for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I need to stop my current medications for the trial?
Yes, you will need to stop taking any prescribed or nonprescribed medications, as the trial excludes participants using these drugs.
Is there any evidence suggesting that AZD4144 is likely to be safe for humans?
Research shows that AZD4144 has undergone testing for safety and tolerability. Previous patients demonstrated that daily intake of AZD4144 is generally well-tolerated, with most side effects being mild and not serious.
The treatment targets a specific protein called NLRP3, and studies indicate it does so effectively without impacting other parts of the body. This suggests that AZD4144 might have fewer unwanted effects.
This study is in the early stages, focusing primarily on understanding safety in healthy individuals. Further studies will offer more information about its safety in larger groups.12345Why are researchers excited about this trial's treatment?
Researchers are excited about AZD4144 because it offers a new approach to treatment by potentially enhancing the effects of medications like rosuvastatin and furosemide. Unlike existing treatments that focus on singular pathways, AZD4144 is being investigated for its ability to work synergistically with other drugs, possibly improving outcomes for patients. This novel mechanism of action could lead to more effective and comprehensive treatment strategies, setting it apart from current options.
What evidence suggests that AZD4144 could be effective?
Research has shown that AZD4144 blocks a protein called NLRP3, which causes inflammation. This protein is linked to conditions where inflammation plays a key role. Studies have found that AZD4144 effectively inhibits NLRP3, suggesting it might help with inflammation-related issues. In this trial, participants will receive either AZD4144 or a placebo to assess its safety and tolerability. Testing so far has shown that AZD4144 is safe and well-tolerated, with no major side effects in healthy individuals. Although information on its effectiveness for specific conditions in humans is limited, its mechanism offers promising potential for treating inflammation-driven diseases.12356
Are You a Good Fit for This Trial?
This trial is for healthy individuals who can participate in a three-part study. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study or pose risks.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part A
Participants receive a single ascending dose of AZD4144 or placebo
Treatment Part B
Participants receive multiple ascending doses of AZD4144 or placebo
Treatment Part C
Participants receive rosuvastatin and furosemide with and without AZD4144 to assess drug-drug interactions
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AZD4144
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