AZD4144 for Healthy Subjects

No longer recruiting at 1 trial location
AC
Overseen ByAstraZeneca Clinical Study Information Center
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: AstraZeneca

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.12345

Why 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

I am not pregnant, not breastfeeding, and cannot become pregnant.
My BMI is between 18 and 32, and I weigh at least 45 kg.
Only healthy Chinese men and women, who are not able to have children, and whose parents and grandparents are all Chinese and have not lived outside of China for more than 10 years, can participate.
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Exclusion Criteria

History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study
History of alcohol abuse or drug abuse
Current smokers or those who have smoked or used nicotine products
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment Part A

Participants receive single ascending doses of AZD4144 or placebo

1 week
Daily visits from Day -1 to Day 4

Follow-up Part A

Participants are monitored for safety and effectiveness after treatment

1 week
1 visit on Day 10

Treatment Part B

Participants receive multiple ascending doses of AZD4144 or placebo

2 weeks
Daily visits from Day -1 to Day 15

Follow-up Part B

Participants are monitored for safety and effectiveness after treatment

1 week
1 visit on Day 20

What Are the Treatments Tested in This Trial?

Interventions

  • AZD4144
Trial Overview The study tests AZD4144's safety and how the body reacts to it when taken orally in different doses. It involves giving either the actual drug (AZD4144) or a placebo to healthy volunteers in separate parts (Part A & B), comparing effects between single doses and multiple doses over time.
How Is the Trial Designed?
18Treatment groups
Experimental Treatment
Placebo Group
Group I: Part B2 (healthy Japanese participants) Cohort 1Experimental Treatment1 Intervention
Group II: Part B1 (healthy participants) Cohort 3Experimental Treatment1 Intervention
Group III: Part B1 (healthy participants) Cohort 2Experimental Treatment1 Intervention
Group IV: Part B1 (healthy participants) Cohort 1Experimental Treatment1 Intervention
Group V: Part A3 (healthy Chinese participants) Cohort 1Experimental Treatment1 Intervention
Group VI: Part A2 (healthy Japanese participants) Cohort 2Experimental Treatment1 Intervention
Group VII: Part A2 (healthy Japanese participants) Cohort 1Experimental Treatment1 Intervention
Group VIII: Part A1 (healthy participants) Cohort 6Experimental Treatment1 Intervention
Group IX: Part A1 (healthy participants) Cohort 5Experimental Treatment1 Intervention
Group X: Part A1 (healthy participants) Cohort 4Experimental Treatment1 Intervention
Group XI: Part A1 (healthy participants) Cohort 3Experimental Treatment1 Intervention
Group XII: Part A1 (healthy participants) Cohort 2Experimental Treatment1 Intervention
Group XIII: Part A1 (healthy participants) Cohort 1Experimental Treatment1 Intervention
Group XIV: Part A3 (healthy Chinese participants) placeboPlacebo Group1 Intervention
Group XV: Part B2 (healthy Japanese participants) placeboPlacebo Group1 Intervention
Group XVI: Part A2 (healthy Japanese participants) placeboPlacebo Group1 Intervention
Group XVII: Part A1 (healthy participants) placeboPlacebo Group1 Intervention
Group XVIII: Part B1 (healthy participants) placeboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

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

Trials
322
Recruited
137,000+
Peyton Howell profile image

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 profile image

Dr. Austin Smith

Parexel

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland

Citations

NCT06491550 | A Study to Assess the Safety, Tolerability ...This study will compare the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD4144 with placebo in healthy participants.
A study to investigate the safety, tolerability and ...The aim of this study is to evaluate the safety and tolerability, and pharmacodynamics (PD) of AZD4144 administered as repeated daily oral dosing.
NCT06925854 | A Study to Investigate How AZD4144 ...This study evaluates how AZD4144 affects rosuvastatin's pharmacokinetics in healthy participants, using a single dose of rosuvastatin alone and with AZD4144.
Discovery of AZD4144, a Selective and Potent NLRP3 ...Compound 1 also showed in vivo inhibition of NLRP3 induced inflammation in the 2 h LPS/ATP model, with a minimum effective dose (MED) of 10 mg/kg. The LPS/ATP- ...
AZD4144 Safety Study in Healthy SubjectsThis study consists of 3 parts: Part A, Part B and Part C. This study will compare the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics ...
NCT06942923 | A Study to Investigate the Safety ...The aim of this study is to evaluate the safety and tolerability, and pharmacodynamics (PD) of AZD4144 administered as repeated daily oral dosing. Detailed ...
A Study to Assess the Safety, Tolerability ...This study will evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple ascending doses of AZD4144 ...
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