Healthy ParticipantsPhase 1NCT05107336
Study to Assess the Safety, Tolerability, and Pharmacokinetics (Movement of Drugs Within the Body) of AZD2693 in Healthy Participants
A Phase 1 study testing AZD2693 in people with Healthy Participants, run by AstraZeneca at 1 site in Japan.
Trial summary
This Phase I, randomised, single-blind, placebo-controlled study has been designed to assess the safety, tolerability, and pharmacokinetics (PK) of AZD2693 following subcutaneous (SC) administration of AZD2693 in healthy participants Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- AZD2693
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteJapan
- Study dates
- 25 Nov 2021to 21 Mar 2023
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
- Participants who are of Japanese ethnicity (Japanese participant is defined as having both parents and 4 grandparents who are ethnically Japanese and this also includes second and third generation Japanese whose parents or grandparents are living in a country other than Japan)
- Participants who are of Non-Asian ethnicities. A Non-Asian Participant is defined as having both parents and grandparents who are ethnically Non-Asian.
- Body mass index within the range 18 to 32 kg/m^2
- Male and/or female participants of non-child bearing potential
Who cannot join
- History of any clinically important disease or disorder
- History or presence of gastrointestinal, hepatic, or renal disease or condition known to interfere with absorption, distribution, metabolism or excretion of drugs
- Participants with known autoimmune disease or on-treatment with immune-modulatory drugs
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first dose of study intervention
- Any clinically significant cardiovascular event within the last 6 months prior to the Screening Visit
- Any clinically important abnormalities in clinical chemistry, haematology or urinalysis results and any abnormal vital signs
Show all 15Show fewer
- Any clinically important abnormalities in rhythm, conduction or morphology of the resting electrocardiogram (ECG) and any clinically important abnormalities in the 12-Lead ECG
- Blood dyscrasias with increased risk of bleeding including idiopathic thrombocytopenic purpura and thrombotic thrombocytopenic purpura or symptoms of increased risk of bleeding
- History of major bleed or high-risk of bleeding diathesis
- Participants with a positive diagnostic nucleic acid test for Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), at Screening Visit. Participants who test positive for Coronavirus disease 2019 (COVID-19) at Screening Visit
- Participants with a significant COVID-19 illness within 6 months of enrollment
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity
- Received another new chemical entity (defined as a compound which has not been approved for marketing) within 30 days of last Follow-up to first dose of study intervention of this study or 5 half-lives from last dose to first dose of study intervention, whichever is the longest
- Participants who have previously received AZD2693
- Previous enrollment or randomization into the present study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Single-Blind, Placebo-Controlled, Phase I Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD2693 Following Multiple Subcutaneous Dose Administration in Healthy Participants
This Phase I, randomised, single-blind, placebo-controlled study has been designed to assess the safety, tolerability, and pharmacokinetics (PK) of AZD2693 following subcutaneous (SC) administration of AZD2693 in healthy participants
Read the detailed description
The study will be performed at a single study center in Japan.
The study will comprise of following periods:
- Screening Period of maximum 28 days.
- An 8-week Treatment Period during which participants will be randomized to receive multiple doses of AZD2693 or placebo at the study center.
- A Follow-up Period of 15 weeks post last dose of study intervention consisting of 8 Follow-up Visits.
Participants will be enrolled in 4 consecutive cohorts of 11 participants where 8 participants will be randomized to receive AZD2693 and 3 participants will be randomized to receive placebo.
A participant is considered to have completed the study if the participant has completed all phases of the study including the last visit.
- Conditions
- Healthy Participants
- Being tested
- AZD2693, Placebo
- Keywords
- Pharmacokinetics, Healthy Japanese Participants, Non-alcoholic fatty liver disease, Non-alcoholic steatohepatitis
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD2693Drug
Participants will receive subcutaneous injection of AZD2693, once per month.
PlaceboDrug
Participants will receive subcutaneous injection of placebo (volume matching to AZD2693 injection [0.9% saline solution]), once per month.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: AZD2693 | Experimental | Japanese Participants will receive Dose A of AZD2693. Receives: Drug: AZD2693 |
| Cohort 2: AZD2693 | Experimental | Japanese Participants will receive Dose B of AZD2693. Receives: Drug: AZD2693 |
| Cohort 3: AZD2693 | Experimental | Japanese Participants will receive Dose C of AZD2693. Receives: Drug: AZD2693 |
| Cohort 4: AZD2693 | Experimental | Non-Asian Participants will receive Dose C of AZD2693 Receives: Drug: AZD2693 |
| Placebo | Placebo comparator | Japanese and Non-Asian Participants will receive placebo matching Dose A, B, and C to AZD2693. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Safety and tolerability of AZD2693 compared to placebo following multiple dose SC administration in healthy participants will be evaluated.
Measured: Until Day 162 (Final/Early termination visit)
Secondary outcomes (28)
Maximum observed plasma drug concentration (Cmax) of AZD2693
Cmax of AZD2693 following single dose SC administration of AZD2693 in healthy participants will be characterized.
Measured: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Time to reach peak or maximum observed concentration following drug administration (tmax) of AZD2693
tmax of AZD2693 following single dose SC administration of AZD2693 in healthy participants will be characterized.
Measured: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Terminal elimination rate constant, estimated by log-linear least-squares regression of the terminal part of the concentration-time curve (λz) of AZD2693
λz of AZD2693 following single and multiple doses SC administration of AZD2693 in healthy participants will be characterized.
Measured: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Apparent terminal elimination half-life associated with the terminal slope (λz) of the semi-logarithmic concentration-time curve (t½λz) of AZD2693
t½λz of AZD2693 following single and multiple doses SC administration of AZD2693 in healthy participants will be characterized. The t½λz , estimated as (ln2)/λz
Measured: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Area under the plasma concentration-time curve from time zero to 48 hours after dosing AUC (0-48) of AZD2693
AUC(0-48) of AZD2693 following single and multiple doses SC administration of AZD2693 in healthy participants will be characterized.
Measured: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Area under the plasma concentration-curve from time zero to the time of last quantifiable analyte concentration (AUClast) of AZD2693
AUClast of AZD2693 following single and multiple doses SC administration of AZD2693 in healthy participants will be characterized.
Measured: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Area under the concentration-time curve from time zero extrapolated to infinity. AUCinf is estimated by AUClast + Clast/ λz where Clast is the last observed quantifiable concentration (AUCinf) of AZD2693
AUCinf of AZD2693 following single dose SC administration of AZD2693 in healthy participants will be characterized.
Measured: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Apparent total body clearance of drug from plasma after extravascular administration (CL/F) of AZD2693
CL/F of AZD2693 following single and multiple dose SC administration of AZD2693 in healthy participants will be characterized. CL/F is calculated as Dose/AUCinf for single dose and for multiple dose it is calculated as Dose/AUCτAUCss.
Measured: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Mean residence time (MRTinf) of AZD2693
MRTinf of AZD2693 following single dose SC administration of AZD2693 in healthy participants will be characterized.
Measured: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Time delay between drug administration and the first observed concentration in plasma (tlag) of AZD2693
tlag of AZD2693 following single and multiple doses SC administration of AZD2693 in healthy participants will be characterized.
Measured: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Apparent volume of distribution for parent drug at terminal phase (extravascular administration) (Vz/F) of AZD2693
Vz/F of AZD2693 following single dose SC administration of AZD2693 in healthy participants will be characterized. Vz/F is estimated by dividing the apparent clearance (CL/F) by λz.
Measured: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Area under the plasma concentration-time curve from time zero to time of last quantifiable analyte concentration divided by the dose administered (AUClast/D) of AZD2693
AUClast/D of AZD2693 following single and multiple doses SC administration of AZD2693 in healthy participants will be characterized.
Measured: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Area under the plasma concentration-time curve from time zero extrapolated to infinity divided by the dose administered (AUCinf/D) of AZD2693
AUCinf/D of AZD2693 following single dose SC administration of AZD2693 in healthy participants will be characterized.
Measured: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Observed maximum plasma concentration divided by the dose administered (Cmax/D) of AZD2693
Cmax/D of AZD2693 following single and multiple doses SC administration of AZD2693 in healthy participants will be characterized.
Measured: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Time of the last quantifiable concentration (tlast) of AZD2693
tlast of AZD2693 following single and multiple doses SC administration of AZD2693 in healthy participants will be characterized.
Measured: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Maximum observed plasma drug concentration at steady state (Cmax) of AZD2693
Cmax of AZD2693 following multiple dose SC administration of AZD2693 in healthy participants will be characterized.
Measured: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Minimum observed drug concentration at steady state (Cmin) of AZD2693
Cmin of AZD2693 following multiple dose SC administration of AZD2693 in healthy participants will be characterized.
Measured: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Time to reach maximum observed plasma concentration at steady state (tmax) of AZD2693
tmax of AZD2693 following multiple dose SC administration of AZD2693 in healthy participants will be characterized.
Measured: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Area under the concentration-time curve in the dose interval (AUCτ) of AZD2693
AUCτ of AZD2693 following multiple dose SC administration of AZD2693 in healthy participants will be characterized.
Measured: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Area under the plasma concentration-time curve from time zero extrapolated to infinity divided by the dose administered (AUCτ/D) of AZD2693
AUCτ/D of AZD2693 following multiple dose SC administration of AZD2693 in healthy participants will be characterized.
Measured: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Accumulation ratio based on Cmax (Rac Cmax) of AZD2693
Rac Cmax of AZD2693 following multiple dose SC administration of AZD2693 in healthy participants will be characterized.
Measured: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Accumulation ratio based on AUC (Rac AUC) of AZD2693
Rac AUC of AZD2693 following multiple dose SC administration of AZD2693 in healthy participants will be characterized.
Measured: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Temporal change parameter in systemic exposure (TCP) of AZD2693
TCP of AZD2693 following multiple dose SC administration of AZD2693 in healthy participants will be characterized.
Measured: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Amount of analyte excreted into the urine from time t1 to t2 (Ae(t1-t2)) for AZD2693
(Ae(t1-t2)) of AZD2693 following single and multiple dose SC administration of AZD2693 in healthy participants will be characterized.
Measured: Day 1 and Day 57 (pre-dose and post-dose)
Cumulative amount of analyte excreted from time zero through the last sampling interval Ae(0-last) of AZD2693
Ae(0-last) of AZD2693 following single and multiple dose SC administration of AZD2693 in healthy participants will be characterized.
Measured: Day 1 and Day 57 (pre-dose and post-dose)
Fraction of dose excreted unchanged into the urine from time t1 to t2 fe(t1-t2) of AZD2693
fe(t1-t2) of AZD2693 following single and multiple dose SC administration of AZD2693 in healthy participants will be characterized.
Measured: Day 1 and Day 57 (pre-dose and post-dose)
Cumulative fraction (percentage) of dose excreted unchanged into the urine from time zero to the last measured time point (fe(0-last)) of AZD2693
fe(0-last) of AZD2693 following single and multiple dose SC administration of AZD2693 in healthy participants will be characterized.
Measured: Day 1 and Day 57 (pre-dose and post-dose)
Renal clearance of drug from plasma, estimated by dividing Ae(0-t) by AUC(0-t) where the 0-t interval is the same for both Ae and AUC (CLR) of AZD2693
CLR of AZD2693 following single and multiple dose SC administration of AZD2693 in healthy participants will be characterized.
Measured: Day 1 and Day 57 (pre-dose and post-dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start25 Nov 2021
- Primary completion21 Mar 2023
- Study completion21 Mar 2023
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05107336
- Sponsor's protocol ID
- D7830C00006
- Status last verified
- Jul 2025
- First submitted
- 25 Oct 2021
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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. 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 shared.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Single-Blind, Placebo-Controlled, Phase I Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD2693 Following Multiple Subcutaneous Dose Administration in Healthy Participants
- ClinicalTrials.gov ID
- NCT05107336
- Acronym / sponsor ID
- D7830C00006
- Conditions
- Healthy Participants
- Keywords
- Pharmacokinetics, Healthy Japanese Participants, Non-alcoholic fatty liver disease, Non-alcoholic steatohepatitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 25 Nov 2021 (actual)
- Primary completion
- 21 Mar 2023 (actual)
- Study completion
- 21 Mar 2023 (actual)
- First posted
- 4 Nov 2021 (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 Phase I, randomised, single-blind, placebo-controlled study has been designed to assess the safety, tolerability, and pharmacokinetics (PK) of AZD2693 following subcutaneous (SC) administration of AZD2693 in healthy participants
Detailed description
The study will be performed at a single study center in Japan.
The study will comprise of following periods:
- Screening Period of maximum 28 days.
- An 8-week Treatment Period during which participants will be randomized to receive multiple doses of AZD2693 or placebo at the study center.
- A Follow-up Period of 15 weeks post last dose of study intervention consisting of 8 Follow-up Visits.
Participants will be enrolled in 4 consecutive cohorts of 11 participants where 8 participants will be randomized to receive AZD2693 and 3 participants will be randomized to receive placebo.
A participant is considered to have completed the study if the participant has completed all phases of the study including the last visit.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: AZD2693 | Experimental | Drug: AZD2693Japanese Participants will receive Dose A of AZD2693. |
| Cohort 2: AZD2693 | Experimental | Drug: AZD2693Japanese Participants will receive Dose B of AZD2693. |
| Cohort 3: AZD2693 | Experimental | Drug: AZD2693Japanese Participants will receive Dose C of AZD2693. |
| Cohort 4: AZD2693 | Experimental | Drug: AZD2693Non-Asian Participants will receive Dose C of AZD2693 |
| Placebo | Placebo comparator | Drug: PlaceboJapanese and Non-Asian Participants will receive placebo matching Dose A, B, and C to AZD2693. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
- Participants who are of Japanese ethnicity (Japanese participant is defined as having both parents and 4 grandparents who are ethnically Japanese and this also includes second and third generation Japanese whose parents or grandparents are living in a country other than Japan)
- Participants who are of Non-Asian ethnicities. A Non-Asian Participant is defined as having both parents and grandparents who are ethnically Non-Asian.
- Body mass index within the range 18 to 32 kg/m^2
- Male and/or female participants of non-child bearing potential
Key exclusion criteria (15 listed)
- History of any clinically important disease or disorder
- History or presence of gastrointestinal, hepatic, or renal disease or condition known to interfere with absorption, distribution, metabolism or excretion of drugs
- Participants with known autoimmune disease or on-treatment with immune-modulatory drugs
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first dose of study intervention
- Any clinically significant cardiovascular event within the last 6 months prior to the Screening Visit
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 |
|---|---|---|
| AZD2693Participants will receive subcutaneous injection of AZD2693, once per month. | Drug | Cohort 1: AZD2693, Cohort 2: AZD2693, Cohort 3: AZD2693, Cohort 4: AZD2693 |
| PlaceboParticipants will receive subcutaneous injection of placebo (volume matching to AZD2693 injection [0.9% saline solution]), once per month. | Drug | Placebo |
Primary outcome
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Until Day 162 (Final/Early termination visit)
Safety and tolerability of AZD2693 compared to placebo following multiple dose SC administration in healthy participants will be evaluated.
28 secondary outcomes
Maximum observed plasma drug concentration (Cmax) of AZD2693
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Time to reach peak or maximum observed concentration following drug administration (tmax) of AZD2693
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Terminal elimination rate constant, estimated by log-linear least-squares regression of the terminal part of the concentration-time curve (λz) of AZD2693
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Apparent terminal elimination half-life associated with the terminal slope (λz) of the semi-logarithmic concentration-time curve (t½λz) of AZD2693
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Area under the plasma concentration-time curve from time zero to 48 hours after dosing AUC (0-48) of AZD2693
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Area under the plasma concentration-curve from time zero to the time of last quantifiable analyte concentration (AUClast) of AZD2693
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Area under the concentration-time curve from time zero extrapolated to infinity. AUCinf is estimated by AUClast + Clast/ λz where Clast is the last observed quantifiable concentration (AUCinf) of AZD2693
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Apparent total body clearance of drug from plasma after extravascular administration (CL/F) of AZD2693
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Mean residence time (MRTinf) of AZD2693
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Time delay between drug administration and the first observed concentration in plasma (tlag) of AZD2693
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Apparent volume of distribution for parent drug at terminal phase (extravascular administration) (Vz/F) of AZD2693
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Area under the plasma concentration-time curve from time zero to time of last quantifiable analyte concentration divided by the dose administered (AUClast/D) of AZD2693
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Area under the plasma concentration-time curve from time zero extrapolated to infinity divided by the dose administered (AUCinf/D) of AZD2693
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Observed maximum plasma concentration divided by the dose administered (Cmax/D) of AZD2693
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Time of the last quantifiable concentration (tlast) of AZD2693
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Maximum observed plasma drug concentration at steady state (Cmax) of AZD2693
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Minimum observed drug concentration at steady state (Cmin) of AZD2693
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Time to reach maximum observed plasma concentration at steady state (tmax) of AZD2693
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Area under the concentration-time curve in the dose interval (AUCτ) of AZD2693
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Area under the plasma concentration-time curve from time zero extrapolated to infinity divided by the dose administered (AUCτ/D) of AZD2693
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Accumulation ratio based on Cmax (Rac Cmax) of AZD2693
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Accumulation ratio based on AUC (Rac AUC) of AZD2693
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Temporal change parameter in systemic exposure (TCP) of AZD2693
Time frame: Day 1 and Day 57 (pre-dose and post-dose), Day 8, Day 29 (pre-dose only), and days 64, 78, 92, 106, 120, 134, 148, and 162 (Final/ET visit)
Amount of analyte excreted into the urine from time t1 to t2 (Ae(t1-t2)) for AZD2693
Time frame: Day 1 and Day 57 (pre-dose and post-dose)
Cumulative amount of analyte excreted from time zero through the last sampling interval Ae(0-last) of AZD2693
Time frame: Day 1 and Day 57 (pre-dose and post-dose)
Fraction of dose excreted unchanged into the urine from time t1 to t2 fe(t1-t2) of AZD2693
Time frame: Day 1 and Day 57 (pre-dose and post-dose)
Cumulative fraction (percentage) of dose excreted unchanged into the urine from time zero to the last measured time point (fe(0-last)) of AZD2693
Time frame: Day 1 and Day 57 (pre-dose and post-dose)
Renal clearance of drug from plasma, estimated by dividing Ae(0-t) by AUC(0-t) where the 0-t interval is the same for both Ae and AUC (CLR) of AZD2693
Time frame: Day 1 and Day 57 (pre-dose and post-dose)
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 20 Jul 2025.
- Redacted CSR synopsis.Link provided by the sponsor.
- 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. 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 shared.
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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 AZD2693 in people with Healthy Participants, run by AstraZeneca at 1 site in Japan.
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 5 inclusion and 15 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 20 Jul 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 Japan. 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. Some participants in this study may receive a placebo. 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?
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Until Day 162 (Final/Early termination visit)). 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 20 Jul 2025.