95 Participants Needed

AZD4144 for Healthy Subjects

Recruiting at 1 trial location
AC
Overseen ByAstraZeneca Clinical Study Information Center
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: AstraZeneca

Trial Summary

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.

What is the purpose of this trial?

This trial tests a new oral drug, AZD4144, in healthy people, including Japanese and Chinese groups. Researchers aim to see how safe it is and how it behaves in the body.

Eligibility Criteria

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
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Timeline

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

Treatment Details

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.
Participant Groups
18Treatment groups
Experimental Treatment
Placebo Group
Group I: Part B2 (healthy Japanese participants) Cohort 1Experimental Treatment1 Intervention
Participants will receive one multiple ascending dose of AZD4144.
Group II: Part B1 (healthy participants) Cohort 3Experimental Treatment1 Intervention
Participants will receive one multiple ascending dose of AZD4144.
Group III: Part B1 (healthy participants) Cohort 2Experimental Treatment1 Intervention
Participants will receive one multiple ascending dose of AZD4144.
Group IV: Part B1 (healthy participants) Cohort 1Experimental Treatment1 Intervention
Participants will receive one multiple ascending dose of AZD4144.
Group V: Part A3 (healthy Chinese participants) Cohort 1Experimental Treatment1 Intervention
Participants will receive one single ascending dose of AZD4144.
Group VI: Part A2 (healthy Japanese participants) Cohort 2Experimental Treatment1 Intervention
Participants will receive one single ascending dose of AZD4144.
Group VII: Part A2 (healthy Japanese participants) Cohort 1Experimental Treatment1 Intervention
Participants will receive one single ascending dose of AZD4144.
Group VIII: Part A1 (healthy participants) Cohort 6Experimental Treatment1 Intervention
Participants will receive one single ascending dose of AZD4144.
Group IX: Part A1 (healthy participants) Cohort 5Experimental Treatment1 Intervention
Participants will receive one single ascending dose of AZD4144.
Group X: Part A1 (healthy participants) Cohort 4Experimental Treatment1 Intervention
Participants will receive one single ascending dose of AZD4144.
Group XI: Part A1 (healthy participants) Cohort 3Experimental Treatment1 Intervention
Participants will receive one single ascending dose of AZD4144.
Group XII: Part A1 (healthy participants) Cohort 2Experimental Treatment1 Intervention
Participants will receive one single ascending dose of AZD4144.
Group XIII: Part A1 (healthy participants) Cohort 1Experimental Treatment1 Intervention
Participants will receive one single ascending dose of AZD4144.
Group XIV: Part A3 (healthy Chinese participants) placeboPlacebo Group1 Intervention
Participants will receive matching placebo.
Group XV: Part B2 (healthy Japanese participants) placeboPlacebo Group1 Intervention
Participants will receive matching placebo.
Group XVI: Part A2 (healthy Japanese participants) placeboPlacebo Group1 Intervention
Participants will receive matching placebo.
Group XVII: Part A1 (healthy participants) placeboPlacebo Group1 Intervention
Participants will receive matching Placebo.
Group XVIII: Part B1 (healthy participants) placeboPlacebo Group1 Intervention
Participants will receive matching placebo.

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

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