A Single and Multiple Ascending Dose Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD2389 in Healthy Participants
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.
1 other identifier
interventional
120
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2023
CompletedFirst Posted
Study publicly available on registry
November 18, 2023
CompletedStudy Start
First participant enrolled
November 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 24, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 24, 2025
CompletedSeptember 9, 2025
September 1, 2025
1.8 years
November 14, 2023
September 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
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
Day 1 and Day 2
Part A (SAD): Urine concentrations of AZD2389
Day 1 and Day 2
Part A (SAD): Terminal rate constant (λz)
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)]
Day 1 and Day 2
Part A (SAD): Area under plasma concentration time curve from zero to infinity (AUCinf)
Day 1 and Day 2
- +34 more secondary outcomes
Study Arms (14)
Cohort 1: Part A1 - AZD2389 dose 1/placebo oral administration
EXPERIMENTALA 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
EXPERIMENTALA 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
EXPERIMENTALA 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
EXPERIMENTALA 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
EXPERIMENTALA 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
EXPERIMENTALA total of 6 study participants will receive a single dose of AZD2389.
Cohort 7: Part A2 - AZD2389 dose 7 /placebo oral administration
EXPERIMENTALA 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
EXPERIMENTALA 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
EXPERIMENTALA 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
EXPERIMENTALA 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
EXPERIMENTALA 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
EXPERIMENTALA 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
EXPERIMENTALA 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
EXPERIMENTALA total of 6 study participants will receive multiple doses of AZD2389 and 2 will receive placebo.
Interventions
Participants will receive AZD2389 orally as a single ascending dose or multiple ascending dose.
Participants will receive placebo matching the AZD2389 dose orally as a single ascending dose or multiple ascending dose.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Research Site
Glendale, California, 91206, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2023
First Posted
November 18, 2023
Study Start
November 20, 2023
Primary Completion
August 24, 2025
Study Completion
August 24, 2025
Last Updated
September 9, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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.