Healthy ParticipantsPhase 1NCT06138795
A Single and Multiple Ascending Dose Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD2389 in Healthy Participants
A Phase 1 study testing AZD2389 in people with Healthy Participants, run by AstraZeneca at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- AZD2389
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2023to 24 Aug 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female (of non-childbearing potential) participants with suitable veins for cannulation or repeated venipuncture.
- For the healthy Japanese cohorts (Parts A2 and B2): healthy participants are to be Japanese (e.g., natives of Japan or Japanese Americans), defined as having both parents and 4 grandparents who are Japanese. This includes healthy second and third generation participants of Japanese descent whose parents or grandparents are living in a country other than Japan.
- For the healthy Chinese cohort (Part A3): healthy participants are to be Chinese defined as having both parents and 4 grandparents who are ethnically Chinese. This includes second and third generation Chinese whose parents or grandparents are living in a country other than China.
Who cannot join
- Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP.
- Known or suspected history of alcohol or drug abuse and smokers.
- Plasma donation within one month of the Screening Visit or any blood donation/blood loss > 500 mL during the 3 months prior to the Screening Visit.
- History of coagulation or bleeding disorders or use of anti-platelets/anti-coagulants during the 3 months prior to the Screening Visit, as judged by the investigator.
- History of hypersensitivity as judged by the investigator, to drugs with a similar chemical structure or class.
- History of severe dermatological disorders, eg, bullous pemphigoid or Stevens-Johnson syndrome, or clinically significant new or healing wounds in areas of the body not always covered by clothing such as face, forearm, and lower leg, as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD2389 After Single and Multiple Ascending Doses to Healthy Participants.
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.
Read the detailed description
This is a Phase I, First In Human (FIH), randomized, single-blind, placebo-controlled, single and multiple ascending dose study in healthy male and/or female participants of non-childbearing potential including healthy participants of Chinese and Japanese ethnicity performed at a single center.
The study consists of 2 parts: Part A and Part B. Part A has been planned to be conducted with 78 participants and Part B has been planned to be conducted with 32 participants.
Each participant in Part A and Part B will be involved in the study for up to 8 weeks.
- Conditions
- Healthy Participants
- Being tested
- AZD2389, Placebo
- Keywords
- Liver disease, Single ascending dose, Multiple ascending dose
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD2389Drug
Participants will receive AZD2389 orally as a single ascending dose or multiple ascending dose.
PlaceboDrug
Participants will receive placebo matching the AZD2389 dose orally as a single ascending dose or multiple ascending dose.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Part A1 - AZD2389 dose 1/placebo oral administration | Experimental | A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo. Receives: Drug: AZD2389; Drug: Placebo |
| Cohort 2: Part A1 - AZD2389 dose 2/placebo oral administration | Experimental | A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo. Receives: Drug: AZD2389; Drug: Placebo |
| Cohort 3: Part A1 - AZD2389 dose 3 /placebo oral administration | Experimental | A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo. Receives: Drug: AZD2389; Drug: Placebo |
| Cohort 4: Part A1 - AZD2389 dose 4 /placebo oral administration | Experimental | A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo. Receives: Drug: AZD2389; Drug: Placebo |
| Cohort 5: Part A1 - AZD2389 dose 5 /placebo oral administration | Experimental | A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo. Receives: Drug: AZD2389; Drug: Placebo |
| Cohort 6: Part A1 - AZD2389 dose 6 oral administration | Experimental | A total of 6 study participants will receive a single dose of AZD2389. Receives: Drug: AZD2389 |
| Cohort 7: Part A2 - AZD2389 dose 7 /placebo oral administration | Experimental | A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo. Receives: Drug: AZD2389; Drug: Placebo |
| Cohort 8: Part A2 - AZD2389 dose 8 /placebo oral administration | Experimental | A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo. Receives: Drug: AZD2389; Drug: Placebo |
| Cohort 9: Part A2 - AZD2389 dose 9 /placebo oral administration | Experimental | A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo. Receives: Drug: AZD2389; Drug: Placebo |
| Cohort 10: Part A3 - AZD2389 dose 10 /placebo oral administration | Experimental | A total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo. Receives: Drug: AZD2389; Drug: Placebo |
| Cohort 11: Part B1 - AZD2389 dose 11 /placebo oral administration | Experimental | A total of 6 study participants will receive multiple doses of AZD2389 and 2 will receive placebo. Receives: Drug: AZD2389; Drug: Placebo |
| Cohort 12: Part B1 - AZD2389 dose 12 /placebo oral administration | Experimental | A total of 6 study participants will receive multiple doses of AZD2389 and 2 will receive placebo. Receives: Drug: AZD2389; Drug: Placebo |
| Cohort 13: Part B1 - AZD2389 dose 13 /placebo oral administration | Experimental | A total of 6 study participants will receive multiple doses of AZD2389 and 2 will receive placebo. Receives: Drug: AZD2389; Drug: Placebo |
| Cohort 14: Part B2- AZD2389 dose 14/placebo oral administration | Experimental | A total of 6 study participants will receive multiple doses of AZD2389 and 2 will receive placebo. Receives: Drug: AZD2389; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A (SAD): Number of participants with adverse events (AE) and serious adverse events (SAE)
To assess the safety and tolerability of AZD2389 following oral administration of single ascending doses in healthy participants, including Japanese and Chinese participants.
Measured: Day ≤ -28 (Only SAE), Day -1 (Only SAE), Days 1 and 2, Day 8 Post-dose (± 1 day)
Part B (MAD): Number of participants with AE and SAE
To assess the safety and tolerability of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants.
Measured: Day ≤ -28 (Only SAE), Day -1 (Only SAE), Days 1 to 12, Day 17 (± 1 day)
Secondary outcomes (39)
Part A (SAD): Plasma concentrations of AZD2389
To characterize the plasma concentration of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants.
Measured: Day 1 and Day 2
Part A (SAD): Urine concentrations of AZD2389
To characterize the urine concentration of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants.
Measured: Day 1 and Day 2
Part A (SAD): Terminal rate constant (λz)
To characterize the λz of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants.
Measured: Day 1 and Day 2
Part A (SAD): Cumulative amount of unchanged drug excreted into urine from time t1 to time t2 [Ae(t1-t2)]
To characterize the Ae(t1-t2) of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants.
Measured: Day 1 and Day 2
Part A (SAD): Area under plasma concentration time curve from zero to infinity (AUCinf)
To characterize the AUCinf of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants.
Measured: Day 1 and Day 2
Part A (SAD): Dose normalized AUCinf (AUCinf/D)
To characterize the AUCinf/D of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants.
Measured: Day 1 and Day 2
Part A (SAD): Area under concentration curve from time 0 to the last quantifiable concentration (AUClast)
To characterize the AUClast of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants.
Measured: Day 1 and Day 2
Part A (SAD): Dose normalized AUClast (AUClast/D)
To characterize the AUClast/D of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants.
Measured: Day 1 and Day 2
Part A (SAD): Apparent total body clearance of drug (CL/F)
To characterize the CL/F of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants.
Measured: Day 1 and Day 2
Part A (SAD): Maximum observed plasma (peak) drug concentration (Cmax)
To characterize the Cmax of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants.
Measured: Day 1 and Day 2
Part A (SAD): Dose normalized Cmax (Cmax/D)
To characterize the Cmax/D of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants.
Measured: Day 1 and Day 2
Part A (SAD): Renal clearance (CLR)
To characterize the CLR of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants.
Measured: Day 1 and Day 2
Part A (SAD): Individual and cumulative percentage of dose excreted unchanged in urine from time t1 to time t2 [fe(t1-t2)]
To characterize the fe(t1-t2) of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants.
Measured: Day 1 and Day 2
Part A (SAD): Mean residence time (MRTinf)
To characterize the MRTinf of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants.
Measured: Day 1 and Day 2
Part A (SAD): Apparent terminal elimination half-life (t½λz)
To characterize the t½λz of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants.
Measured: Day 1 and Day 2
Part A (SAD): Time of last quantifiable concentration (tlast)
To characterize the tlast of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants.
Measured: Day 1 and Day 2
Part A (SAD): Time to reach peak or maximum observed concentration (tmax)
To characterize the tmax of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants.
Measured: Day 1 and Day 2
Part A (SAD): Apparent volume of distribution based on the terminal phase (Vz/F)
To characterize the Vz/F of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants.
Measured: Day 1 and Day 2
Part A (SAD): Change in PD biomarkers over time
To characterize the percentage change in PD biomarkers over time compared to baseline of AZD2389 after single oral dosing in healthy participants, including Japanese and Chinese participants.
Measured: Day 1 and Day 2
Part B (MAD): Plasma concentrations of AZD2389
To characterize the plasma concentration of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants.
Measured: Day 1 to Day 12
Part B (MAD): Urine concentrations of AZD2389
To characterize the urine concentration of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants.
Measured: Day 1 and Days 10 to 12
Part B (MAD): Terminal rate constant (λz)
To characterize the λz of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants.
Measured: Day 1 to Day 12
Part B (MAD): Cumulative amount of unchanged drug excreted into urine from time t1 to time t2 [Ae(t1-t2)]
To characterize the Ae(t1-t2) of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants.
Measured: Day 1 and Days 10 to 12
Part B (MAD): Area under concentration curve from time 0 to the last quantifiable concentration (AUClast)
To characterize the AUClast of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants.
Measured: Day 1 to Day 12
Part B (MAD): Area under the concentration-time curve in the dose interval (AUCtau)
To characterize the AUCtau of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants.
Measured: Day 1 to Day 12
Part B (MAD): Dose normalized AUCtau (AUCtau/D)
To characterize the AUCtau/D of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants.
Measured: Day 1 to Day 12
Part B (MAD): Dose normalized AUClast (AUClast/D)
To characterize the AUClast/D of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants.
Measured: Day 1 to Day 12
Part B (MAD): Apparent total body clearance of drug (CL/F)
To characterize the CL/F of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants.
Measured: Day 1 and Days 10 to 12
Part B (MAD): Renal clearance (CLR)
To characterize the CLR of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants.
Measured: Day 1 and Days 10 to 12
Part B (MAD): Maximum observed plasma (peak) drug concentration (Cmax)
To characterize the Cmax of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants.
Measured: Day 1 to Day 12
Part B (MAD): Dose normalized Cmax (Cmax/D)
To characterize the Cmax/D of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants.
Measured: Day 1 to Day 12
Part B (MAD): Observed lowest concentration before the next dose is administered(Ctrough)
To characterize the Ctrough of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants.
Measured: Day 1 to Day 12
Part B (MAD): Individual and cumulative percentage of dose excreted unchanged in urine from time t1 to time t2 [fe(t1-t2)]
To characterize the fe(t1-t2) of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants.
Measured: Day 1 and Days 10 to 12
Part B (MAD): Accumulation ratio for AUC (Rac AUC)
To characterize the Rac AUC of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants.
Measured: Day 1 to Day 12
Part B (MAD): Accumulation ratio for Cmax (Rac Cmax)
To characterize the Rac Cmax of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants.
Measured: Day 1 to Day 12
Part B (MAD): Time to reach peak or maximum observed concentration (tmax)
To characterize the tmax of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants.
Measured: Day 1 to Day 12
Part B (MAD): Apparent terminal elimination half-life (t½λz)
To characterize the t½λz of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants.
Measured: Day 1 to Day 12
Part B (MAD): Apparent volume of distribution based on the terminal phase (Vz/F)
To characterize the Vz/F of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants.
Measured: Day 1 to Day 12
Part B (MAD): Change in PD biomarkers over time
To characterize the percentage change in PD biomarkers over time compared to baseline of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants.
Measured: Days 1, 2, 4, 8, and 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start20 Nov 2023
- Primary completion24 Aug 2025
- Study completion24 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Placebo-controlled
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06138795
- Sponsor's protocol ID
- D7930C00001
- Status last verified
- Sep 2025
- First submitted
- 14 Nov 2023
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD2389 After Single and Multiple Ascending Doses to Healthy Participants.
- ClinicalTrials.gov ID
- NCT06138795
- Acronym / sponsor ID
- D7930C00001
- Conditions
- Healthy Participants
- Keywords
- Liver disease, Single ascending dose, Multiple ascending dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 24 Aug 2025 (actual)
- Study completion
- 24 Aug 2025 (actual)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a Phase I, First In Human (FIH), randomized, single-blind, placebo-controlled, single and multiple ascending dose study in healthy male and/or female participants of non-childbearing potential including healthy participants of Chinese and Japanese ethnicity performed at a single center.
The study consists of 2 parts: Part A and Part B. Part A has been planned to be conducted with 78 participants and Part B has been planned to be conducted with 32 participants.
Each participant in Part A and Part B will be involved in the study for up to 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 14
- Model description
- Placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Part A1 - AZD2389 dose 1/placebo oral administration | Experimental | Drug: AZD2389, Drug: PlaceboA total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo. |
| Cohort 2: Part A1 - AZD2389 dose 2/placebo oral administration | Experimental | Drug: AZD2389, Drug: PlaceboA total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo. |
| Cohort 3: Part A1 - AZD2389 dose 3 /placebo oral administration | Experimental | Drug: AZD2389, Drug: PlaceboA total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo. |
| Cohort 4: Part A1 - AZD2389 dose 4 /placebo oral administration | Experimental | Drug: AZD2389, Drug: PlaceboA total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo. |
| Cohort 5: Part A1 - AZD2389 dose 5 /placebo oral administration | Experimental | Drug: AZD2389, Drug: PlaceboA total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo. |
| Cohort 6: Part A1 - AZD2389 dose 6 oral administration | Experimental | Drug: AZD2389A total of 6 study participants will receive a single dose of AZD2389. |
| Cohort 7: Part A2 - AZD2389 dose 7 /placebo oral administration | Experimental | Drug: AZD2389, Drug: PlaceboA total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo. |
| Cohort 8: Part A2 - AZD2389 dose 8 /placebo oral administration | Experimental | Drug: AZD2389, Drug: PlaceboA total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo. |
| Cohort 9: Part A2 - AZD2389 dose 9 /placebo oral administration | Experimental | Drug: AZD2389, Drug: PlaceboA total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo. |
| Cohort 10: Part A3 - AZD2389 dose 10 /placebo oral administration | Experimental | Drug: AZD2389, Drug: PlaceboA total of 6 study participants will receive a single dose of AZD2389 and 2 will receive placebo. |
| Cohort 11: Part B1 - AZD2389 dose 11 /placebo oral administration | Experimental | Drug: AZD2389, Drug: PlaceboA total of 6 study participants will receive multiple doses of AZD2389 and 2 will receive placebo. |
| Cohort 12: Part B1 - AZD2389 dose 12 /placebo oral administration | Experimental | Drug: AZD2389, Drug: PlaceboA total of 6 study participants will receive multiple doses of AZD2389 and 2 will receive placebo. |
| Cohort 13: Part B1 - AZD2389 dose 13 /placebo oral administration | Experimental | Drug: AZD2389, Drug: PlaceboA total of 6 study participants will receive multiple doses of AZD2389 and 2 will receive placebo. |
| Cohort 14: Part B2- AZD2389 dose 14/placebo oral administration | Experimental | Drug: AZD2389, Drug: PlaceboA total of 6 study participants will receive multiple doses of AZD2389 and 2 will receive placebo. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male and female (of non-childbearing potential) participants with suitable veins for cannulation or repeated venipuncture.
- For the healthy Japanese cohorts (Parts A2 and B2): healthy participants are to be Japanese (e.g., natives of Japan or Japanese Americans), defined as having both parents and 4 grandparents who are Japanese. This includes healthy second and third generation participants of Japanese descent whose parents or grandparents are living in a country other than Japan.
- For the healthy Chinese cohort (Part A3): healthy participants are to be Chinese defined as having both parents and 4 grandparents who are ethnically Chinese. This includes second and third generation Chinese whose parents or grandparents are living in a country other than China.
Key exclusion criteria (6 listed)
- Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP.
- Known or suspected history of alcohol or drug abuse and smokers.
- Plasma donation within one month of the Screening Visit or any blood donation/blood loss > 500 mL during the 3 months prior to the Screening Visit.
- History of coagulation or bleeding disorders or use of anti-platelets/anti-coagulants during the 3 months prior to the Screening Visit, as judged by the investigator.
- History of hypersensitivity as judged by the investigator, to drugs with a similar chemical structure or class.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD2389Participants will receive AZD2389 orally as a single ascending dose or multiple ascending dose. | Drug | Cohort 10: Part A3 - AZD2389 dose 10 /placebo oral administration, Cohort 11: Part B1 - AZD2389 dose 11 /placebo oral administration, Cohort 12: Part B1 - AZD2389 dose 12 /placebo oral administration, Cohort 13: Part B1 - AZD2389 dose 13 /placebo oral administration, Cohort 14: Part B2- AZD2389 dose 14/placebo oral administration, Cohort 1: Part A1 - AZD2389 dose 1/placebo oral administration, Cohort 2: Part A1 - AZD2389 dose 2/placebo oral administration, Cohort 3: Part A1 - AZD2389 dose 3 /placebo oral administration, Cohort 4: Part A1 - AZD2389 dose 4 /placebo oral administration, Cohort 5: Part A1 - AZD2389 dose 5 /placebo oral administration, Cohort 6: Part A1 - AZD2389 dose 6 oral administration, Cohort 7: Part A2 - AZD2389 dose 7 /placebo oral administration, Cohort 8: Part A2 - AZD2389 dose 8 /placebo oral administration, Cohort 9: Part A2 - AZD2389 dose 9 /placebo oral administration |
| PlaceboParticipants will receive placebo matching the AZD2389 dose orally as a single ascending dose or multiple ascending dose. | Drug | Cohort 10: Part A3 - AZD2389 dose 10 /placebo oral administration, Cohort 11: Part B1 - AZD2389 dose 11 /placebo oral administration, Cohort 12: Part B1 - AZD2389 dose 12 /placebo oral administration, Cohort 13: Part B1 - AZD2389 dose 13 /placebo oral administration, Cohort 14: Part B2- AZD2389 dose 14/placebo oral administration, Cohort 1: Part A1 - AZD2389 dose 1/placebo oral administration, Cohort 2: Part A1 - AZD2389 dose 2/placebo oral administration, Cohort 3: Part A1 - AZD2389 dose 3 /placebo oral administration, Cohort 4: Part A1 - AZD2389 dose 4 /placebo oral administration, Cohort 5: Part A1 - AZD2389 dose 5 /placebo oral administration, Cohort 7: Part A2 - AZD2389 dose 7 /placebo oral administration, Cohort 8: Part A2 - AZD2389 dose 8 /placebo oral administration, Cohort 9: Part A2 - AZD2389 dose 9 /placebo oral administration |
Primary outcome
Part A (SAD): Number of participants with adverse events (AE) and serious adverse events (SAE)
Time frame: Day ≤ -28 (Only SAE), Day -1 (Only SAE), Days 1 and 2, Day 8 Post-dose (± 1 day)
To assess the safety and tolerability of AZD2389 following oral administration of single ascending doses in healthy participants, including Japanese and Chinese participants.
Part B (MAD): Number of participants with AE and SAE
Time frame: Day ≤ -28 (Only SAE), Day -1 (Only SAE), Days 1 to 12, Day 17 (± 1 day)
To assess the safety and tolerability of AZD2389 following oral administration of multiple ascending doses in healthy participants, including Japanese participants.
39 secondary outcomes
Part A (SAD): Plasma concentrations of AZD2389
Time frame: Day 1 and Day 2
Part A (SAD): Urine concentrations of AZD2389
Time frame: Day 1 and Day 2
Part A (SAD): Terminal rate constant (λz)
Time frame: Day 1 and Day 2
Part A (SAD): Cumulative amount of unchanged drug excreted into urine from time t1 to time t2 [Ae(t1-t2)]
Time frame: Day 1 and Day 2
Part A (SAD): Area under plasma concentration time curve from zero to infinity (AUCinf)
Time frame: Day 1 and Day 2
Part A (SAD): Dose normalized AUCinf (AUCinf/D)
Time frame: Day 1 and Day 2
Part A (SAD): Area under concentration curve from time 0 to the last quantifiable concentration (AUClast)
Time frame: Day 1 and Day 2
Part A (SAD): Dose normalized AUClast (AUClast/D)
Time frame: Day 1 and Day 2
Part A (SAD): Apparent total body clearance of drug (CL/F)
Time frame: Day 1 and Day 2
Part A (SAD): Maximum observed plasma (peak) drug concentration (Cmax)
Time frame: Day 1 and Day 2
Part A (SAD): Dose normalized Cmax (Cmax/D)
Time frame: Day 1 and Day 2
Part A (SAD): Renal clearance (CLR)
Time frame: Day 1 and Day 2
Part A (SAD): Individual and cumulative percentage of dose excreted unchanged in urine from time t1 to time t2 [fe(t1-t2)]
Time frame: Day 1 and Day 2
Part A (SAD): Mean residence time (MRTinf)
Time frame: Day 1 and Day 2
Part A (SAD): Apparent terminal elimination half-life (t½λz)
Time frame: Day 1 and Day 2
Part A (SAD): Time of last quantifiable concentration (tlast)
Time frame: Day 1 and Day 2
Part A (SAD): Time to reach peak or maximum observed concentration (tmax)
Time frame: Day 1 and Day 2
Part A (SAD): Apparent volume of distribution based on the terminal phase (Vz/F)
Time frame: Day 1 and Day 2
Part A (SAD): Change in PD biomarkers over time
Time frame: Day 1 and Day 2
Part B (MAD): Plasma concentrations of AZD2389
Time frame: Day 1 to Day 12
Part B (MAD): Urine concentrations of AZD2389
Time frame: Day 1 and Days 10 to 12
Part B (MAD): Terminal rate constant (λz)
Time frame: Day 1 to Day 12
Part B (MAD): Cumulative amount of unchanged drug excreted into urine from time t1 to time t2 [Ae(t1-t2)]
Time frame: Day 1 and Days 10 to 12
Part B (MAD): Area under concentration curve from time 0 to the last quantifiable concentration (AUClast)
Time frame: Day 1 to Day 12
Part B (MAD): Area under the concentration-time curve in the dose interval (AUCtau)
Time frame: Day 1 to Day 12
Part B (MAD): Dose normalized AUCtau (AUCtau/D)
Time frame: Day 1 to Day 12
Part B (MAD): Dose normalized AUClast (AUClast/D)
Time frame: Day 1 to Day 12
Part B (MAD): Apparent total body clearance of drug (CL/F)
Time frame: Day 1 and Days 10 to 12
Part B (MAD): Renal clearance (CLR)
Time frame: Day 1 and Days 10 to 12
Part B (MAD): Maximum observed plasma (peak) drug concentration (Cmax)
Time frame: Day 1 to Day 12
Part B (MAD): Dose normalized Cmax (Cmax/D)
Time frame: Day 1 to Day 12
Part B (MAD): Observed lowest concentration before the next dose is administered(Ctrough)
Time frame: Day 1 to Day 12
Part B (MAD): Individual and cumulative percentage of dose excreted unchanged in urine from time t1 to time t2 [fe(t1-t2)]
Time frame: Day 1 and Days 10 to 12
Part B (MAD): Accumulation ratio for AUC (Rac AUC)
Time frame: Day 1 to Day 12
Part B (MAD): Accumulation ratio for Cmax (Rac Cmax)
Time frame: Day 1 to Day 12
Part B (MAD): Time to reach peak or maximum observed concentration (tmax)
Time frame: Day 1 to Day 12
Part B (MAD): Apparent terminal elimination half-life (t½λz)
Time frame: Day 1 to Day 12
Part B (MAD): Apparent volume of distribution based on the terminal phase (Vz/F)
Time frame: Day 1 to Day 12
Part B (MAD): Change in PD biomarkers over time
Time frame: Days 1, 2, 4, 8, and 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD2389 in people with Healthy Participants, run by AstraZeneca at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A (SAD): Number of participants with adverse events (AE) and serious adverse events (SAE) (time frame: Day ≤ -28 (Only SAE), Day -1 (Only SAE), Days 1 and 2, Day 8 Post-dose (± 1 day)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.