AZD4144 for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called AZD4144 to determine its safety and tolerability in healthy individuals. Researchers aim to understand how the body processes the drug in both single and multiple doses. The trial includes different parts for healthy participants, with specific groups for those of Japanese and Chinese descent. Individuals who are generally healthy, can confirm their ancestry as required, and meet certain health criteria may be suitable for this study. 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 information does not specify whether you need to stop taking your current medications. However, since the study is for healthy participants, it is likely that you should not be on any regular medications.
Is there any evidence suggesting that AZD4144 is likely to be safe for humans?
Research has shown that AZD4144 has been tested for safety in healthy individuals. In earlier studies, participants took AZD4144 in both single and repeated doses to observe their bodily reactions. The results indicated that most tolerated the treatment well, without serious side effects.
Some mild side effects, such as headaches or mild stomach upset, were noted, which are common with many treatments. These studies involved healthy individuals to help researchers understand the drug's safety before testing it in people with health conditions.
This current study is a Phase 1 trial, focusing on the safety and correct dosing of AZD4144. This early phase is crucial for identifying potential risks before proceeding to larger studies.12345Why do researchers think this study treatment might be promising?
Researchers are excited about AZD4144 because it offers a new approach to treatment by focusing on its unique mechanism of action. While most treatments for various conditions typically work by targeting specific symptoms or pathways, AZD4144 is designed to act on a different cellular mechanism, potentially offering a more effective and targeted therapy. This novel approach could lead to better outcomes with fewer side effects, making it a promising candidate in the field of experimental treatments. Additionally, the ability to use both single and multiple ascending doses allows researchers to finely tune the treatment's effectiveness and safety, paving the way for more personalized medicine.
What evidence suggests that AZD4144 could be effective?
Research has shown that AZD4144 is designed to block the NLRP3 inflammasome, a component of the body's system that triggers inflammation. In animal studies, AZD4144 effectively reduced inflammation at a dose of 10 mg/kg, suggesting it might help manage conditions caused by excessive inflammation. However, most studies have focused on the drug's mechanism and safety in humans, rather than its efficacy in treating specific diseases. This trial will examine the effects of AZD4144 in healthy participants across various treatment arms, including different dosages and placebo comparisons. While the potential appears promising, more research in humans is necessary to confirm its benefits for treating conditions.12367
Are You a Good Fit for This Trial?
This trial is for healthy adults with a BMI of 18-32 and weight over 45 kg. Women must not be pregnant or nursing, and participants should have no history of significant illness that could affect drug absorption or pose risks. Specific cohorts include Chinese individuals who haven't lived outside China for over 10 years, and Japanese participants including second/third generation descendants.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 single ascending doses of AZD4144 or placebo
Follow-up Part A
Participants are monitored for safety and effectiveness after treatment
Treatment Part B
Participants receive multiple ascending doses of AZD4144 or placebo
Follow-up Part B
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
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