Apply to Trial

Compensation: Varies

Number of Visits: 13

91 Participants Needed

AZD4144 Safety Study in Healthy Subjects

Recruiting at 1 trial location

Overseen ByAstraZeneca Clinical Study Information Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: AstraZeneca

Must not be taking: Enzyme inducers, Hormonal contraceptives

Disqualifiers: Gastrointestinal, Hepatic, Renal, Infections, others

What You Need to Know Before You Apply

What is the purpose of this trial?

This study consists of 3 parts: Part A, Part B and Part C. This study will compare the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD4144 with placebo in healthy participants, in Part A and Part B. Part C of this study will investigate the possibility of drug-drug interaction (DDI) between IV AZD4144 and oral rosuvastatin and furosemide by evaluating the PK of rosuvastatin and furosemide when administered alone and in combination with single IV dose of AZD4144

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.

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

For healthy Japanese cohorts: healthy male and female participants are to be Japanese, defined as having both parents and 4 grandparents who are Japanese. This includes second and third generation participants of Japanese descent whose parents or grandparents are living in a country other than Japan

I am a man who can father children and will use birth control.

I am a woman who cannot become pregnant, confirmed at my screening visit.

See 4 more

Exclusion Criteria

I have a condition that makes me more likely to get infections.

I do not have any serious ongoing infections.

I have a history of tuberculosis.

See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment Part A

Participants receive a single ascending dose of AZD4144 or placebo

4 days

Residential stay from Day -1 to Day 4

Treatment Part B

Participants receive multiple ascending doses of AZD4144 or placebo

15 days

Residential stay from Day -1 to Day 15

Treatment Part C

Participants receive rosuvastatin and furosemide with and without AZD4144 to assess drug-drug interactions

12 days

Residential stay from Day -1 to Day 3 and Day 9 to Day 12

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 days after last dose

Final follow-up visit on Day 10+3 for Part A and Day 20+3 for Part B and C

What Are the Treatments Tested in This Trial?

Interventions

AZD4144

Trial Overview The trial tests AZD4144's safety, tolerability, how it's processed by the body (pharmacokinetics), and its effects on the body (pharmacodynamics) compared to a placebo. It also examines if AZD4144 affects how rosuvastatin, a cholesterol medication, works when both drugs are taken together.

How Is the Trial Designed?

17Treatment groups

Experimental Treatment

Placebo Group

Group I: Part C cohort- Treatment C2Experimental Treatment1 Intervention

Participants will receive rosuvastatin, furosemide, and AZD4144.

Group II: Part C Cohort- Treatment C1Experimental Treatment1 Intervention

Participants will receive rosuvastatin and furosemide.

Group III: Part B2- Japanese CohortExperimental Treatment1 Intervention

Participants will receive multiple ascending doses of AZD4144.

Group IV: Part B1- Cohort 3Experimental Treatment1 Intervention

Participants will receive multiple ascending doses of AZD4144.

Group V: Part B1- Cohort 2Experimental Treatment1 Intervention

Participants will receive multiple ascending doses of AZD4144.

Group VI: Part B1- Cohort 1Experimental Treatment1 Intervention

Participants will receive multiple ascending doses of AZD4144.

Group VII: Part A3-Chinese CohortExperimental Treatment1 Intervention