AZD2389 Safety and Pharmacokinetics in Healthy Subjects

Overseen By AstraZeneca Clinical Study Information Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: AstraZeneca

Must not be taking: Anti-platelets, Anti-coagulants

Disqualifiers: Alcohol abuse, Drug abuse, Smoking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

120 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those with a history of using anti-platelets or anti-coagulants in the past 3 months. It's best to discuss your specific medications with the trial team.

What is the purpose of this trial?

This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AZD2389 following single and multiple dose administration (SAD/MAD) to healthy participants.

Eligibility Criteria

Healthy adults with a BMI of 18-32 and weight over 50 kg can join. Women must not be able to bear children, and men must use contraception. Participants should have good veins for blood draws, no serious health issues or drug abuse history, not smoke or drink excessively, and avoid certain medications before the trial. Specific groups include Japanese or Chinese descent individuals.

Inclusion Criteria

If you want to join the study as a healthy Chinese person, your parents and all four grandparents must be ethnically Chinese. This also applies to second or third generation Chinese people whose parents or grandparents live in a country other than China.

I am healthy, can't become pregnant, and have good veins for drawing blood.

I am not pregnant, not breastfeeding, and cannot become pregnant.

Exclusion Criteria

Any clinically important abnormalities in clinical chemistry, haematology, or urinalysis results

Known or suspected history of alcohol or drug abuse or excessive intake of alcohol as judged by the investigator or any participant (male or female) who consumes more than one standard alcoholic drink per day on a regular basis in the 6 months prior to screening and as judged by the investigator

I have a long-term blood disorder.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A (SAD)

Participants receive single ascending doses of AZD2389 or placebo

2 weeks

Multiple visits for dosing and monitoring

Treatment Part B (MAD)

Participants receive multiple ascending doses of AZD2389 or placebo

4 weeks

Frequent visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• AZD2389
• Placebo

Trial Overview The study is testing AZD2389's safety and how it affects the body when given once (SAD) or multiple times (MAD). It compares AZD2389 against a placebo in healthy people to see what happens to the drug in their bodies and how they respond to it.

Participant Groups

Group I: Cohort 9: Part A2 - AZD2389 dose 9 /placebo oral administration Experimental Treatment 2 Interventions

A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo.

Group II: Cohort 8: Part A2 - AZD2389 dose 8 /placebo oral administration Experimental Treatment 2 Interventions

A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo.

Group III: Cohort 7: Part A2 - AZD2389 dose 7 /placebo oral administration Experimental Treatment 2 Interventions

A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo.

Group IV: Cohort 6: Part A1 - AZD2389 dose 6 oral administration Experimental Treatment 1 Intervention

A total of 6 study participants will receive a single dose of AZD2389.

Group V: Cohort 5: Part A1 - AZD2389 dose 5 /placebo oral administration Experimental Treatment 2 Interventions

A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo.

Group VI: Cohort 4: Part A1 - AZD2389 dose 4 /placebo oral administration Experimental Treatment 2 Interventions

A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo.

Group VII: Cohort 3: Part A1 - AZD2389 dose 3 /placebo oral administration Experimental Treatment 2 Interventions

A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo.

Group VIII: Cohort 2: Part A1 - AZD2389 dose 2/placebo oral administration Experimental Treatment 2 Interventions

A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo.

Group IX: Cohort 1: Part A1 - AZD2389 dose 1/placebo oral administration Experimental Treatment 2 Interventions

A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo.

Group X: Cohort 14: Part B2- AZD2389 dose 14/placebo oral administration Experimental Treatment 2 Interventions

A total of 6 study participants will receive multiple doses of AZD2389 and 2 will receive placebo.

Group XI: Cohort 13: Part B1 - AZD2389 dose 13 /placebo oral administration Experimental Treatment 2 Interventions

A total of 6 study participants will receive multiple doses of AZD2389 and 2 will receive placebo.

Group XII: Cohort 12: Part B1 - AZD2389 dose 12 /placebo oral administration Experimental Treatment 2 Interventions

A total of 6 study participants will receive multiple doses of AZD2389 and 2 will receive placebo.

Group XIII: Cohort 11: Part B1 - AZD2389 dose 11 /placebo oral administration Experimental Treatment 2 Interventions

A total of 6 study participants will receive multiple doses of AZD2389 and 2 will receive placebo.

Group XIV: Cohort 10: Part A3 - AZD2389 dose 10 /placebo oral administration Experimental Treatment 2 Interventions

A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo.

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