SafetyPhase 1NCT05143905
A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7503 in Healthy Participants
A Phase 1 study testing AZD7503 in people with Safety and Tolerability, run by AstraZeneca at 1 site in United States.
Trial summary
This study will evaluate safety, tolerability and pharmacokinetics (PK) of AZD7503, following subcutaneous (SC) administration of single ascending doses of AZD7503 in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety, Tolerability, Pharmacokinetics
- What is being tested?
- AZD7503
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2021to 9 Nov 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy non smoking male and/or female (of non childbearing potential) participants with suitable veins for cannulation or repeated venipuncture.
- Females must have a negative pregnancy test at screening and on admission to the study centre, must not be lactating and must be of non childbearing potential.
- Body mass index (BMI) between 18 and 30 kg/m^2, inclusive, and weigh at least 60 kg for healthy participants or between 18 and 32 kg/m^2, inclusive, and weigh at least 50 kg for Japanese and Chinese participants.
- For Japanese and Chinese participants:
- A Japanese participant is defined as having both parents and 4 grandparents who are ethnically Japanese. This includes first-, second-and third-generation Japanese whose parents or grandparents are living in a country other than Japan.
- A Chinese participant is defined as having both parents and 4 grandparents who are ethnically Chinese. This includes first-, second-and third-generation Chinese whose parents or grandparents are living in a country other than China.
- Willing to participate in retrospective genotyping analysis for HSD17B13.
Who cannot join
- History of any clinically important disease or disorder.
- 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 within 4 weeks of administration of study intervention.
- Any laboratory values with the following deviations at screening and/or Day 1:
- Alanine aminotransferase > Upper Limit of Normal (ULN)
- Aspartate aminotransferase > ULN
Show all 28Show fewer
- Total bilirubin > ULN
- Creatinine > ULN
- White blood cell count < Lower Limit of Normal (LLN)
- Hemoglobin < LLN
- Estimated glomerular filtration rate < 60 mL/min/1.73 m^2
- Platelets >ULN and/or <LLN.
- Any clinically important abnormalities in clinical chemistry, hematology or urinalysis results other than those described above, including participants with platelet or bleeding disorders, known platelet dysfunction disorders.
- Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody or Human Immunodeficiency Virus.
- Confirmed coronavirus disease 2019 (COVID-19) infection during screening and/or admission by polymerase chain reaction (PCR) test.
- Abnormal vital signs, after 5 minutes supine rest
- Any clinically important abnormalities in rhythm, conduction or morphology of the resting electrocardiogram (ECG) and any clinically important abnormalities in the 12 lead ECG.
- Current smokers or those who have smoked or used nicotine products (including e cigarettes) within the previous 3 months.
- History of alcohol abuse or excessive intake of alcohol
- History of Drug abuse or positive screen for drug of abuse or cotinine (nicotine) or alcohol.
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity or history of hypersensitivity to drugs with a similar chemical structure or class to AZD7503.
- Excessive intake of caffeine containing drinks or food (eg, coffee, tea, chocolate)
- Use of any prescribed or non prescribed medication during the 2 weeks prior to the administration of study intervention or longer if the medication has a long half-life.
- Plasma donation within one month of screening or any blood donation/blood loss more than 500 mL during the 3 months prior to screening.
- Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 30 days (or 5 half lives, whichever is longer) of the administration of study intervention in this study.
- Any ongoing or recent (ie, during the screening period) minor medical complaints.
- Previous bone marrow transplant.
- Non leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Randomised Single-blind Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7503 Following Single Ascending Dose Administration to Healthy Participants
This study will evaluate safety, tolerability and pharmacokinetics (PK) of AZD7503, following subcutaneous (SC) administration of single ascending doses of AZD7503 in healthy participants.
Read the detailed description
This is a Phase I, First-in-Human, study in healthy males and females (non-childbearing potential) participants. In this study up to four dose levels of AZD7503 are planned to be evaluated.
The planned doses of AZD7503 are dose 1, dose 2, dose 3, and dose 4. Eligible participants will be randomised to receive either AZD7503 or placebo. The study will include four single dose cohorts with an option to include two cohorts based on emerging data from planned cohorts in the study and two additional cohorts of Japanese participants and one cohort of Chinese participants will also be included.
Dosing for each ascending dose cohort will be proceeded with sentinel dosing strategy. Here, sentinel sub-cohort will be included, such that 1 participant will be randomised to receive placebo and 1 participant will be randomised to receive AZD7503. The safety data from the sentinel participants up to 24 hours post-dose will be reviewed by the Principal Investigator (PI) before the remaining participants in the cohort are dosed
The study will comprise:
- A Screening Period of maximum 28 days;
- A Treatment Period during which participants will be resident at the Study Centre from the day before study medication administration (Day -1) until at least 72 hours after study medication administration; discharged from the Study Centre on Day 4;
- Follow-up Visits on 1,2,4,6 and 8 weeks; and
- A Final Follow-up Visit 10 weeks after the last study medication dose. Each participant will be involved in the study for approximately 14 weeks.
- Conditions
- Safety, Tolerability, Pharmacokinetics, Healthy Participants
- Being tested
- AZD7503, Placebo
- Keywords
- First-in-Human, Placebo-controlled, AZD7503, Single Ascending Dose, Sentinel Dosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD7503Drug
Randomised participants will receive a single ascending dose of AZD7503 by SC injection (dose 1, dose 2, dose 3, dose 4, dose X and dose Y).
PlaceboDrug
Randomised participants will receive placebo by SC injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: AZD7503 dose 1 | Experimental | Randomised healthy participants will receive a single dose 1 of AZD7503. Receives: Drug: AZD7503 |
| Cohort 2: AZD7503 dose 2 | Experimental | Randomised healthy participants will receive a single dose 2 of AZD7503. Receives: Drug: AZD7503 |
| Cohort 3: AZD7503 dose 3 | Experimental | Randomised healthy participants will receive a single dose 3 of AZD7503. Receives: Drug: AZD7503 |
| Cohort 4: AZD7503 dose 4 | Experimental | Randomised healthy participants will receive a single dose 4 of AZD7503. Receives: Drug: AZD7503 |
| Cohort 5 : AZD7503 dose X | Experimental | Randomised healthy participants will receive a single dose X of AZD7503. Receives: Drug: AZD7503 |
| Cohort 6: AZD7503 dose Y | Experimental | Randomised healthy participants will receive a single dose Y of AZD7503. Receives: Drug: AZD7503 |
| Pooled Placebo for AZD7503 (Cohorts 1 to 6) | Placebo comparator | Randomised healthy participants will receive placebo. Receives: Drug: Placebo |
| Japanese Cohort 1: AZD7503 dose 3 | Experimental | Randomised healthy Japanese participants will receive a single dose 3 of AZD7503. Receives: Drug: AZD7503 |
| Japanese Cohort 2: AZD7503 dose 4 | Experimental | Randomised healthy Japanese participants will receive a single dose 4 of AZD7503. Receives: Drug: AZD7503 |
| Placebo (Japanese Cohorts) | Placebo comparator | Randomised healthy Japanese participants will receive placebo. Receives: Drug: Placebo |
| Chinese Cohort: AZD7503 dose 4 | Experimental | Randomised healthy Chinese participants will receive a single dose 4 of AZD7503. Receives: Drug: AZD7503 |
| Placebo (Chinese Cohort) | Placebo comparator | Randomised healthy Chinese participants will 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 (AEs)
To assess adverse events as a variable of safety and tolerability of AZD7503 following SC single dose administration.
Measured: Up to Final Follow-up (FU) Visit (Week 10) or Early Termination (ET) (assessed up to 14 Weeks)
Secondary outcomes (14)
Area under plasma concentration time-curve from zero to infinity (AUCinf) of AZD7503
To characterise the PK (AUCinf) of AZD7503 following SC administration of single ascending doses of AZD7503.
Measured: (Pre-dose and Post-dose) Days 1 to 4 and final FU visit (Week 10 post last dose) or ET (assessed up to 14 Weeks)
Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast) of AZD7503
To characterise the PK (AUClast) of AZD7503 following SC administration of single ascending doses of AZD7503.
Measured: (Pre-dose and Post-dose) Days 1 to 4 and final FU visit (Week 10 post last dose) or ET (assessed up to 14 Weeks)
Maximum observed plasma (peak) drug concentration (Cmax) of AZD7503
To characterise the PK (Cmax) of AZD7503 following SC administration of single ascending doses of AZD7503.
Measured: (Pre-dose and Post-dose) Days 1 to 4 and final FU visit (Week 10 post last dose) or ET (assessed up to 14 Weeks)
Time to reach peak or maximum observed concentration or response following drug administration (tmax) of AZD7503
To characterise the PK (tmax) of AZD7503 following SC administration of single ascending doses of AZD7503.
Measured: (Pre-dose and Post-dose) Days 1 to 4 and final FU visit (Week 10 post last dose) or ET (assessed up to 14 Weeks)
Time of last observed (quantifiable) concentration (tlast) of AZD7503
To characterise the PK (tlast) of AZD7503 following SC administration of single ascending doses of AZD7503.
Measured: (Pre-dose and Post-dose) Days 1 to 4 and final FU visit (Week 10 post last dose) or ET (assessed up to 14 Weeks)
Partial area under the plasma concentration-time curve from time 0 to time 48 hours post dose [AUC(0-48)] of AZD7503
To characterise the PK [AUC(0-48)] of AZD7503 following SC administration of single ascending doses of AZD7503.
Measured: (Pre-dose and Post-dose) Days 1 to 4 and final FU visit (Week 10 post last dose) or ET (assessed up to 14 Weeks)
Half-life associated with terminal slope (λz) of a semi logarithmic concentration time curve (t½λz) of AZD7503
To characterise the PK (t½λz) of AZD7503 following SC administration of single ascending doses of AZD7503.
Measured: (Pre-dose and Post-dose) Days 1 to 4 and final FU visit (Week 10 post last dose) or ET (assessed up to 14 Weeks)
Mean residence time of the unchanged drug in the systemic circulation (MRTinf) of AZD7503
To characterise the PK (MRTinf) of AZD7503 following SC administration of single ascending doses of AZD7503.
Measured: (Pre-dose and Post-dose) Days 1 to 4 and final FU visit (Week 10 post last dose) or ET (assessed up to 14 Weeks)
Apparent total body clearance of drug from plasma after extravascular administration (CL/F) of AZD7503
To characterise the PK (CL/F) of AZD7503 following SC administration of single ascending doses of AZD7503.
Measured: (Pre-dose and Post-dose) Days 1 to 4 and final FU visit (Week 10 post last dose) or ET (assessed up to 14 Weeks)
Apparent volume of distribution at steady state following extravascular administration (Vz/F) of AZD7503
To characterise the PK (Vz/F) of AZD7503 following SC administration of single ascending doses of AZD7503.
Measured: (Pre-dose and Post-dose) Days 1 to 4 and final FU visit (Week 10 post last dose) or ET (assessed up to 14 Weeks)
Cumulative amount of unchanged drug excreted into urine from time t1 to time t2 [Ae(t1-t2)] of AZD7503
To characterise the PK [Ae(t1-t2)] of AZD7503 following SC administration of single ascending doses of AZD7503.
Measured: (Pre-dose and Post-dose) Days 1 to 4
Percentage of dose excreted unchanged in urine from time t1 to t2 [Fe(t1-t2)] of AZD7503
To characterise the PK [Fe(t1-t2)] of AZD7503 following SC administration of single ascending doses of AZD7503.
Measured: (Pre-dose and Post-dose) Days 1 to 4
Renal clearance of drug from plasma (CLR) of AZD7503
To characterise the PK (CLR) of AZD7503 following SC administration of single ascending doses of AZD7503.
Measured: (Pre-dose and Post-dose) Days 1 to 4
Number of participants with positive anti-drug antibodies (ADA) of AZD7503
To explore the formation of ADAs.
Measured: Day -1 to final FU visit (Week 10 post last dose) or ET (assessed up to 14 Weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start6 Dec 2021
- Primary completion9 Nov 2022
- Study completion9 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SafetyStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05143905
- Sponsor's protocol ID
- D9230C00001
- Status last verified
- Feb 2025
- First submitted
- 23 Nov 2021
- Last updated
- 19 Feb 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. 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 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Randomised Single-blind Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7503 Following Single Ascending Dose Administration to Healthy Participants
- ClinicalTrials.gov ID
- NCT05143905
- Acronym / sponsor ID
- D9230C00001
- Conditions
- Safety, Tolerability, Pharmacokinetics, Healthy Participants
- Keywords
- First-in-Human, Placebo-controlled, AZD7503, Single Ascending Dose, Sentinel Dosing
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 6 Dec 2021 (actual)
- Primary completion
- 9 Nov 2022 (actual)
- Study completion
- 9 Nov 2022 (actual)
- First posted
- 3 Dec 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 study will evaluate safety, tolerability and pharmacokinetics (PK) of AZD7503, following subcutaneous (SC) administration of single ascending doses of AZD7503 in healthy participants.
Detailed description
This is a Phase I, First-in-Human, study in healthy males and females (non-childbearing potential) participants. In this study up to four dose levels of AZD7503 are planned to be evaluated.
The planned doses of AZD7503 are dose 1, dose 2, dose 3, and dose 4. Eligible participants will be randomised to receive either AZD7503 or placebo. The study will include four single dose cohorts with an option to include two cohorts based on emerging data from planned cohorts in the study and two additional cohorts of Japanese participants and one cohort of Chinese participants will also be included.
Dosing for each ascending dose cohort will be proceeded with sentinel dosing strategy. Here, sentinel sub-cohort will be included, such that 1 participant will be randomised to receive placebo and 1 participant will be randomised to receive AZD7503. The safety data from the sentinel participants up to 24 hours post-dose will be reviewed by the Principal Investigator (PI) before the remaining participants in the cohort are dosed
The study will comprise:
- A Screening Period of maximum 28 days;
- A Treatment Period during which participants will be resident at the Study Centre from the day before study medication administration (Day -1) until at least 72 hours after study medication administration; discharged from the Study Centre on Day 4;
- Follow-up Visits on 1,2,4,6 and 8 weeks; and
- A Final Follow-up Visit 10 weeks after the last study medication dose. Each participant will be involved in the study for approximately 14 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, care provider)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: AZD7503 dose 1 | Experimental | Drug: AZD7503Randomised healthy participants will receive a single dose 1 of AZD7503. |
| Cohort 2: AZD7503 dose 2 | Experimental | Drug: AZD7503Randomised healthy participants will receive a single dose 2 of AZD7503. |
| Cohort 3: AZD7503 dose 3 | Experimental | Drug: AZD7503Randomised healthy participants will receive a single dose 3 of AZD7503. |
| Cohort 4: AZD7503 dose 4 | Experimental | Drug: AZD7503Randomised healthy participants will receive a single dose 4 of AZD7503. |
| Cohort 5 : AZD7503 dose X | Experimental | Drug: AZD7503Randomised healthy participants will receive a single dose X of AZD7503. |
| Cohort 6: AZD7503 dose Y | Experimental | Drug: AZD7503Randomised healthy participants will receive a single dose Y of AZD7503. |
| Pooled Placebo for AZD7503 (Cohorts 1 to 6) | Placebo comparator | Drug: PlaceboRandomised healthy participants will receive placebo. |
| Japanese Cohort 1: AZD7503 dose 3 | Experimental | Drug: AZD7503Randomised healthy Japanese participants will receive a single dose 3 of AZD7503. |
| Japanese Cohort 2: AZD7503 dose 4 | Experimental | Drug: AZD7503Randomised healthy Japanese participants will receive a single dose 4 of AZD7503. |
| Placebo (Japanese Cohorts) | Placebo comparator | Drug: PlaceboRandomised healthy Japanese participants will receive placebo. |
| Chinese Cohort: AZD7503 dose 4 | Experimental | Drug: AZD7503Randomised healthy Chinese participants will receive a single dose 4 of AZD7503. |
| Placebo (Chinese Cohort) | Placebo comparator | Drug: PlaceboRandomised healthy Chinese participants will receive placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy non smoking male and/or female (of non childbearing potential) participants with suitable veins for cannulation or repeated venipuncture.
- Females must have a negative pregnancy test at screening and on admission to the study centre, must not be lactating and must be of non childbearing potential.
- Body mass index (BMI) between 18 and 30 kg/m^2, inclusive, and weigh at least 60 kg for healthy participants or between 18 and 32 kg/m^2, inclusive, and weigh at least 50 kg for Japanese and Chinese participants.
- For Japanese and Chinese participants:
- Willing to participate in retrospective genotyping analysis for HSD17B13.
Key exclusion criteria (28 listed)
- History of any clinically important disease or disorder.
- 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 within 4 weeks of administration of study intervention.
- Any laboratory values with the following deviations at screening and/or Day 1:
- Any clinically important abnormalities in clinical chemistry, hematology or urinalysis results other than those described above, including participants with platelet or bleeding disorders, known platelet dysfunction disorders.
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 |
|---|---|---|
| AZD7503Randomised participants will receive a single ascending dose of AZD7503 by SC injection (dose 1, dose 2, dose 3, dose 4, dose X and dose Y). | Drug | Chinese Cohort: AZD7503 dose 4, Cohort 1: AZD7503 dose 1, Cohort 2: AZD7503 dose 2, Cohort 3: AZD7503 dose 3, Cohort 4: AZD7503 dose 4, Cohort 5 : AZD7503 dose X, Cohort 6: AZD7503 dose Y, Japanese Cohort 1: AZD7503 dose 3, Japanese Cohort 2: AZD7503 dose 4 |
| PlaceboRandomised participants will receive placebo by SC injection | Drug | Placebo (Chinese Cohort), Placebo (Japanese Cohorts), Pooled Placebo for AZD7503 (Cohorts 1 to 6) |
Primary outcome
Number of participants with Adverse Events (AEs)
Time frame: Up to Final Follow-up (FU) Visit (Week 10) or Early Termination (ET) (assessed up to 14 Weeks)
To assess adverse events as a variable of safety and tolerability of AZD7503 following SC single dose administration.
14 secondary outcomes
Area under plasma concentration time-curve from zero to infinity (AUCinf) of AZD7503
Time frame: (Pre-dose and Post-dose) Days 1 to 4 and final FU visit (Week 10 post last dose) or ET (assessed up to 14 Weeks)
Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast) of AZD7503
Time frame: (Pre-dose and Post-dose) Days 1 to 4 and final FU visit (Week 10 post last dose) or ET (assessed up to 14 Weeks)
Maximum observed plasma (peak) drug concentration (Cmax) of AZD7503
Time frame: (Pre-dose and Post-dose) Days 1 to 4 and final FU visit (Week 10 post last dose) or ET (assessed up to 14 Weeks)
Time to reach peak or maximum observed concentration or response following drug administration (tmax) of AZD7503
Time frame: (Pre-dose and Post-dose) Days 1 to 4 and final FU visit (Week 10 post last dose) or ET (assessed up to 14 Weeks)
Time of last observed (quantifiable) concentration (tlast) of AZD7503
Time frame: (Pre-dose and Post-dose) Days 1 to 4 and final FU visit (Week 10 post last dose) or ET (assessed up to 14 Weeks)
Partial area under the plasma concentration-time curve from time 0 to time 48 hours post dose [AUC(0-48)] of AZD7503
Time frame: (Pre-dose and Post-dose) Days 1 to 4 and final FU visit (Week 10 post last dose) or ET (assessed up to 14 Weeks)
Half-life associated with terminal slope (λz) of a semi logarithmic concentration time curve (t½λz) of AZD7503
Time frame: (Pre-dose and Post-dose) Days 1 to 4 and final FU visit (Week 10 post last dose) or ET (assessed up to 14 Weeks)
Mean residence time of the unchanged drug in the systemic circulation (MRTinf) of AZD7503
Time frame: (Pre-dose and Post-dose) Days 1 to 4 and final FU visit (Week 10 post last dose) or ET (assessed up to 14 Weeks)
Apparent total body clearance of drug from plasma after extravascular administration (CL/F) of AZD7503
Time frame: (Pre-dose and Post-dose) Days 1 to 4 and final FU visit (Week 10 post last dose) or ET (assessed up to 14 Weeks)
Apparent volume of distribution at steady state following extravascular administration (Vz/F) of AZD7503
Time frame: (Pre-dose and Post-dose) Days 1 to 4 and final FU visit (Week 10 post last dose) or ET (assessed up to 14 Weeks)
Cumulative amount of unchanged drug excreted into urine from time t1 to time t2 [Ae(t1-t2)] of AZD7503
Time frame: (Pre-dose and Post-dose) Days 1 to 4
Percentage of dose excreted unchanged in urine from time t1 to t2 [Fe(t1-t2)] of AZD7503
Time frame: (Pre-dose and Post-dose) Days 1 to 4
Renal clearance of drug from plasma (CLR) of AZD7503
Time frame: (Pre-dose and Post-dose) Days 1 to 4
Number of participants with positive anti-drug antibodies (ADA) of AZD7503
Time frame: Day -1 to final FU visit (Week 10 post last dose) or ET (assessed up to 14 Weeks)
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 19 Feb 2025.
- CSR Synopsis RedactedLink provided by the sponsor.
- Results of this clinical trial are available on www.astrazenecaclinicaltrials.comLink 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 AZD7503 in people with Safety and Tolerability, 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 7 inclusion and 28 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 19 Feb 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. 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) (time frame: Up to Final Follow-up (FU) Visit (Week 10) or Early Termination (ET) (assessed up to 14 Weeks)). 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 19 Feb 2025.