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Compensation: Varies

Number of Visits: 4

95 Participants Needed

AZD4144 for Healthy Subjects

Recruiting at 1 trial location

Overseen ByAstraZeneca Clinical Study Information Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: AstraZeneca

Disqualifiers: Gastrointestinal, Hepatic, Renal, Infections, others

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