Heathy ParticipantsPhase 1NCT06093542
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of AZD7503 in Japanese Healthy Participants.
A Phase 1 study testing AZD7053 in people with Heathy Participants, run by AstraZeneca at 1 site in Japan.
Trial summary
The study will evaluate the safety, tolerability, and the pharmacokinetics (PK) of AZD7503 following multiple subcutaneous doses in healthy Japanese participants. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Heathy Participants
- What is being tested?
- AZD7053
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteJapan
- Study dates
- 25 Oct 2023to 20 Mar 2024
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- For Japanese participants: A Japanese participant is defined as having both parents and 4 Japanese grandparents as confirmed by the interview. This includes second and third generation Japanese whose parents or grandparents are living in a country other than Japan. Participants must have suitable veins for cannulation.
- Females must be of non-childbearing potential.
- Males and females must adhere to the contraception methods.
- Have a Body mass index between 18 and 30 kg/m2 inclusive.
Who cannot join
- History of any clinically significant disease or disorder in the investigator's opinion.
- History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any clinically important illness, medical/surgical procedure or trauma.
- Any abnormal laboratory values, clinical chemistry, hematology or urinalysis results, vital signs, Electrocardiography.
- Any clinically significant cardiovascular event.
- Participants with known autoimmune disease or on-treatment with immune-modulatory drugs.
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- Any positive result at the Screening Visit for serum Hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency virus.
- Confirmed COVID-19 infection during screening as per local guidelines.
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity.
- Use of any prescribed or nonprescribed medication.
- History of major bleed or high-risk of bleeding diathesis.
- Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of study intervention.
- Participants who have previously received AZD7503 or any investigational drug targeting HSD17B13.
- Vulnerable participants.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Single-blind, Single Center, Placebo-controlled, Phase I Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD7503 Following Multiple Subcutaneous Dose Administration in Healthy Japanese Participants.
The study will evaluate the safety, tolerability, and the pharmacokinetics (PK) of AZD7503 following multiple subcutaneous doses in healthy Japanese participants.
Read the detailed description
This is a Phase I, randomised, single-blind, placebo-controlled study. The healthy Japanese participants will receive randomly (3:1) either AZD7503 or placebo subcutaneously.
The study will comprise of:
- A screening period of 28 days.
- Randomization on Day 1.
- A 9-week Treatment Period. Dose 1 will be administered on Day 1. Dose 2 will be administered at the study site on Day 29. Dose 3 will be administered on Day 57.
- A follow-up period of 10 week after last dose of study intervention.
- The total duration of the study will be 23 weeks
- Conditions
- Heathy Participants
- Being tested
- AZD7053, Placebo
- Keywords
- Non-alcoholic Fatty Liver Disease cirrhosis, N-acetyl galactosamine-conjugated antisense oligonucleotide, HSD17B13 protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD7053Drug
Randomised participants will receive AZD7503 subcutaneously.
PlaceboDrug
Randomised participants will receive placebo subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| AZD7503 | Experimental | Participants will subcutaneously receive AZD7503. Receives: Drug: AZD7053 |
| Placebo | Placebo comparator | Participants will subcutaneously receive placebo. 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
The safety and tolerability after multiple doses of AZD7503 in healthy Japanese participants will be evaluated.
Measured: From Screening (Day -28) until Follow-up Day 127 (10 weeks post last dose)
Secondary outcomes (8)
Maximum plasma drug concentration (Cmax)
The Cmax after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated.
Measured: Day 1, Day 2, Day 3, Day 5, Day 15, Day 29, Day 57, Day 58, and Day 59
Are under plasma concentration-time curve from time 0 to the last quantifiable concentration (AUClast)
The AUClast after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated.
Measured: Day 1, Day 2, Day 3, Day 5, Day 15, Day 29, Day 57, Day 58, and Day 59
Area under plasma concentration-time curve from time 0 to infinity (AUCinf)
The AUCinf after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated.
Measured: Day 1, Day 2, Day 3, Day 5, Day 15, Day 29, Day 57, Day 58, and Day 59
Area under plasma concentration-time curve during a dosing interval (AUCtau)
The AUCtau after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated.
Measured: Day 1, Day 2, Day 3, Day 5, Day 15, Day 29, Day 57, Day 58, and Day 59
Amount of analyte excreted into the urine (Ae)
The Ae after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated.
Measured: Day 1, Day 2, Day 3, Day 58, and Day 59
Fraction of the dose excreted unchanged in urine (Fe)
The Fe after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated.
Measured: Day 1, Day 2, Day 3, Day 58, and Day 59
Plasma concentration of AZD7503
The plasma concentration after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated.
Measured: Day 1, Day 2, Day 3, Day 58, and Day 59
Plasma concentration of unconjugated antisense oligonucleotide (ASO)
The plasma concentration of unconjugated ASO at specified timepoints after administration of multiple doses of AZD7503 in healthy Japanese participants will be evaluated.
Measured: Day 1, Day 2, Day 3, Day 58, and Day 59
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start25 Oct 2023
- Primary completion20 Mar 2024
- Study completion20 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heathy 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06093542
- Sponsor's protocol ID
- D9230C00005
- Status last verified
- Jul 2025
- First submitted
- 17 Oct 2023
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
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, Single Center, Placebo-controlled, Phase I Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD7503 Following Multiple Subcutaneous Dose Administration in Healthy Japanese Participants.
- ClinicalTrials.gov ID
- NCT06093542
- Acronym / sponsor ID
- D9230C00005
- Conditions
- Heathy Participants
- Keywords
- Non-alcoholic Fatty Liver Disease cirrhosis, N-acetyl galactosamine-conjugated antisense oligonucleotide, HSD17B13 protein
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2023 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 20 Mar 2024 (actual)
- First posted
- 23 Oct 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.
The study will evaluate the safety, tolerability, and the pharmacokinetics (PK) of AZD7503 following multiple subcutaneous doses in healthy Japanese participants.
Detailed description
This is a Phase I, randomised, single-blind, placebo-controlled study. The healthy Japanese participants will receive randomly (3:1) either AZD7503 or placebo subcutaneously.
The study will comprise of:
- A screening period of 28 days.
- Randomization on Day 1.
- A 9-week Treatment Period. Dose 1 will be administered on Day 1. Dose 2 will be administered at the study site on Day 29. Dose 3 will be administered on Day 57.
- A follow-up period of 10 week after last dose of study intervention.
- The total duration of the study will be 23 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AZD7503 | Experimental | Drug: AZD7053Participants will subcutaneously receive AZD7503. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will subcutaneously receive placebo. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- For Japanese participants: A Japanese participant is defined as having both parents and 4 Japanese grandparents as confirmed by the interview. This includes second and third generation Japanese whose parents or grandparents are living in a country other than Japan. Participants must have suitable veins for cannulation.
- Females must be of non-childbearing potential.
- Males and females must adhere to the contraception methods.
- Have a Body mass index between 18 and 30 kg/m2 inclusive.
Key exclusion criteria (14 listed)
- History of any clinically significant disease or disorder in the investigator's opinion.
- History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- Any clinically important illness, medical/surgical procedure or trauma.
- Any abnormal laboratory values, clinical chemistry, hematology or urinalysis results, vital signs, Electrocardiography.
- Any clinically significant cardiovascular event.
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 |
|---|---|---|
| AZD7053Randomised participants will receive AZD7503 subcutaneously. | Drug | AZD7503 |
| PlaceboRandomised participants will receive placebo subcutaneously. | Drug | Placebo |
Primary outcome
Number of participants with adverse events
Time frame: From Screening (Day -28) until Follow-up Day 127 (10 weeks post last dose)
The safety and tolerability after multiple doses of AZD7503 in healthy Japanese participants will be evaluated.
8 secondary outcomes
Maximum plasma drug concentration (Cmax)
Time frame: Day 1, Day 2, Day 3, Day 5, Day 15, Day 29, Day 57, Day 58, and Day 59
Are under plasma concentration-time curve from time 0 to the last quantifiable concentration (AUClast)
Time frame: Day 1, Day 2, Day 3, Day 5, Day 15, Day 29, Day 57, Day 58, and Day 59
Area under plasma concentration-time curve from time 0 to infinity (AUCinf)
Time frame: Day 1, Day 2, Day 3, Day 5, Day 15, Day 29, Day 57, Day 58, and Day 59
Area under plasma concentration-time curve during a dosing interval (AUCtau)
Time frame: Day 1, Day 2, Day 3, Day 5, Day 15, Day 29, Day 57, Day 58, and Day 59
Amount of analyte excreted into the urine (Ae)
Time frame: Day 1, Day 2, Day 3, Day 58, and Day 59
Fraction of the dose excreted unchanged in urine (Fe)
Time frame: Day 1, Day 2, Day 3, Day 58, and Day 59
Plasma concentration of AZD7503
Time frame: Day 1, Day 2, Day 3, Day 58, and Day 59
Plasma concentration of unconjugated antisense oligonucleotide (ASO)
Time frame: Day 1, Day 2, Day 3, Day 58, and Day 59
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\_D9230C00005Link provided by the sponsor.
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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 AZD7053 in people with Heathy 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 4 inclusion and 14 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 (time frame: From Screening (Day -28) until Follow-up Day 127 (10 weeks post last dose)). 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.