Healthy VolunteersPhase 1NCT04269031
A First-in-human Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD2373 After Single Dose Administration in Healthy Male Subjects of African Ancestry.
A Phase 1 study testing AZD2373 subcutaneous injection in people with Healthy Volunteers, run by AstraZeneca at 1 site in United States.
Trial summary
This is a Phase 1 study to assess the the safety, tolerability and pharmacokinetics (PK) of AZD2373, following subcutaneous (SC) administration of single ascending doses (SAD) of AZD2373 in healthy male subjects of African ancestry. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- AZD2373 subcutaneous injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2020to 31 Aug 2021
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Healthy male subjects of West African ancestry aged 18 to 55 years (inclusive, at time of informed consent) with suitable veins for cannulation or repeated venipuncture.
- Have a body mass index (BMI) between 18 and 35 kg/m^2 (inclusive) and weigh at least 50 kg and no more than 120 kg (inclusive).
- Provision of signed, written and dated informed consent for study participation which includes mandatory genotyping (study objective). NOTE: If a subject would decline to participate in the mandatory genotyping component of the study, the subject will not be included in the study.
Who cannot join
- Subjects with known ancestry outside of West Africa.
- History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- 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 prior to administration of IMP on Study Day 1.
- Any laboratory values with the following deviations:
- Alanine aminotransferase or aspartate aminotransferase greater than upper limit of normal and clinically significant as determined by the PI.
Show all 9Show fewer
- White blood cell (WBC) count < 3.0 x 10^9/L.
- Hemoglobin (Hb) below lower limit normal .
- Any clinically important abnormalities in clinical chemistry, hematology or urinalysis results, other than those described above, as judged by the PI.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, First-in-Human, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2373 Following Single Ascending Dose Administrations to Healthy Male Subjects of African Ancestry
This is a Phase 1 study to assess the the safety, tolerability and pharmacokinetics (PK) of AZD2373, following subcutaneous (SC) administration of single ascending doses (SAD) of AZD2373 in healthy male subjects of African ancestry.
Read the detailed description
This study will be conducted as a single-centre, randomised, placebo-controlled, single-blind study to assess the effect of AZD2373 following ascending dose sequential group design administrations to healthy male subjects of African ancestry. The study will include 6 single dose cohorts with the option to include 2 additional cohorts based on emerging data from preceding cohorts in the study.
Approximately 48 male subjects aged 18 to 55 years at the time of informed consent (inclusive) will be randomized with the aim to have 8 subjects participate in each cohort. Within each cohort, 6 subjects will receive AZD2373 and 2 subjects will receive placebo.
Sentinel dosing will be applied for each cohort and will be divided into 2 groups:
- Group 1 (sentinel group): 1 active, 1 placebo;
- Group 2 (the rest of the cohort): 5 active, 1 placebo. The safety data of up to 72 hours post-dose in Group 1 will be reviewed by the Principal Investigator (PI) before the subjects in Group 2 are dosed.
The study will comprise:
- A Screening Period of maximum 35 days;
- A Treatment Period during which subjects will be resident at the Clinical Unit from the day before investigational medicinal product (IMP) administration (Day -1) until at least 72 hours after IMP administration; discharged from the Clinical Unit on Day 4;
- Follow-up Visits on 1, 1.5, 2, 3, 4, 5, 6, and 8 weeks (Visits 3 to 10); and
- A Final Follow up Visit 10 weeks after the last IMP dose.
The visit occurring at 5 weeks post dose (Visit 5) is optional. The expected duration for any subject participating in the study is approximately 10 weeks (excluding an up to 28-day Screening Period).
- Conditions
- Healthy Volunteers
- Being tested
- AZD2373 subcutaneous injection, Placebo
- Keywords
- First-in-Human, Randomized, Single-blind, Placebo controlled, AZD2373, Single Ascending Dose, Sentinel Dosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD2373 subcutaneous injectionDrug
Randomised subjects will receive a single ascending dose of AZD2373 by SC injection (dose 1, dose 2, dose 3, dose 4, dose 5 and dose 6).
PlaceboDrug
Randomised subjects will receive a single ascending dose of placebo (saline solution) by SC injection.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | On Day 1, randomized subjects will receive a subcutaneous (SC) injection of AZD2373 dose 1 (6 subjects) or matching placebo (2 subjects). Receives: Drug: AZD2373 subcutaneous injection; Drug: Placebo |
| Cohort 2 | Experimental | On Day 1, randomized subjects will receive a SC injection of AZD2373 dose 2 (6 subjects) or matching placebo (2 subjects). Receives: Drug: AZD2373 subcutaneous injection; Drug: Placebo |
| Cohort 3 | Experimental | On Day 1, randomized subjects will receive a SC injection of AZD2373 dose 3 (6 subjects) or matching placebo (2 subjects). Receives: Drug: AZD2373 subcutaneous injection; Drug: Placebo |
| Cohort 4 | Experimental | On Day 1, randomized subjects will receive a SC injection of AZD2373 dose 4 (6 subjects) or matching placebo (2 subjects). Receives: Drug: AZD2373 subcutaneous injection; Drug: Placebo |
| Cohort 5 | Experimental | On Day 1, randomized subjects will receive a SC injection of AZD2373 dose 5 (6 subjects) or matching placebo (2 subjects). Receives: Drug: AZD2373 subcutaneous injection; Drug: Placebo |
| Cohort 6 | Experimental | On Day 1, randomized subjects will receive a SC injection of AZD2373 dose 6 (6 subjects) or matching placebo (2 subjects). Receives: Drug: AZD2373 subcutaneous injection; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events and/or abnormal findings in vital signs, and/or clinical laboratory assessments and/or physical examination and/or electrocardiogram (ECG) evaluation and/or telemetry and/or injection site reactions
To assess adverse events as a variable of safety and tolerability of subcutaneous (SC) single ascending dose (SAD) administrations of AZD2373
Measured: Screening Visit to final Follow-up Visit (Week 10 post last dose)
Secondary outcomes (17)
Area under plasma concentration-time curve from time zero extrapolated to infinity (AUC)
To characterize the PK of AZD2373 following SC SAD administrations of AZD2373.
Measured: Visit 2 to final Follow-up Visit (Week 10 post last dose)
Area under the plasma concentration curve from time zero to the time of last quantifiable analyte concentration (AUClast)
To characterize the PK of AZD2373 following SC SAD administrations of AZD2373.
Measured: Visit 2 to final Follow-up Visit (Week 10 post last dose)
Area under the plasma concentration-time curve from time zero to 72 hours after dosing [AUC(0-72)]
To characterize the PK of AZD2373 following SC SAD administrations of AZD2373.
Measured: Visit 2 to final Follow-up Visit (Week 10 post last dose)
Area under the plasma concentration-time curve from time zero to 48 hours after dosing [AUC (0-48)]
To characterize the PK of AZD2373 following SC SAD administrations of AZD2373.
Measured: Visit 2 to final Follow-up Visit (Week 10 post last dose)
Observed maximum plasma concentration (Cmax)
To characterize the PK of AZD2373 following SC SAD administrations of AZD2373.
Measured: Visit 2 to final Follow-up Visit (Week 10 post last dose)
Time to reach peak or maximum observed concentration or response following drug administration (tmax)
To characterize the PK of AZD2373 following SC SAD administrations of AZD2373.
Measured: Visit 2 to final Follow-up Visit (Week 10 post last dose)
Half-life associated with terminal slope (λz) of a semi logarithmic concentration-time curve (t½λz)
To characterize the PK of AZD2373 following SC SAD administrations of AZD2373.
Measured: Visit 2 to final Follow-up Visit (Week 10 post last dose)
Apparent total body clearance of drug from plasma after extravascular administration [CL/F]
To characterize the PK of AZD2373 following SC SAD administrations of AZD2373.
Measured: Visit 2 to final Follow-up Visit (Week 10 post last dose)
Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)
To characterize the PK of AZD2373 following SC SAD administrations of AZD2373.
Measured: Visit 2 to final Follow-up Visit (Week 10 post last dose)
Mean residence time of the unchanged drug in the systemic circulation (MRT)
To characterize the PK of AZD2373 following SC SAD administrations of AZD2373.
Measured: Visit 2 to final Follow-up Visit (Week 10 post last dose)
Terminal elimination rate constant (λz)
To characterize the PK of AZD2373 following SC SAD administrations of AZD2373.
Measured: Visit 2 to final Follow-up Visit (Week 10 post last dose)
Time of the last quantifiable concentration [tlast Ae(0-last)]
To characterize the PK of AZD2373 following SC SAD administrations of AZD2373.
Measured: Visit 2 to final Follow-up Visit (Week 10 post last dose)
Cumulative fraction (%) of dose excreted unchanged into the urine from time zero to the last measured time point [fe(0-last)]
To characterize the PK of AZD2373 following SC SAD administrations of AZD2373.
Measured: Visit 2 to final Follow-up Visit (Week 10 post last dose)
Amount of analyte excreted into the urine from time t1 to t2 [Ae(t1-t2)]
To characterize the PK of AZD2373 following SC SAD administrations of AZD2373.
Measured: Visit 2 to final Follow-up Visit (Week 10 post last dose)
Fraction of dose excreted unchanged into the urine from time t1 to t2 [fe(t1-t2)]
To characterize the PK of AZD2373 following SC SAD administrations of AZD2373.
Measured: Visit 2 to final Follow-up Visit (Week 10 post last 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)
To characterize the PK of AZD2373 following SC SAD administrations of AZD2373.
Measured: Visit 2 to final Follow-up Visit (Week 10 post last dose)
Apolipoprotein L1 (APOL1) concentrations and change from baseline
To assess the effect of SC SAD administrations of AZD2373 on plasma concentrations of APOL1 protein
Measured: Visit 2 to final Follow-up Visit (Week 10 post last dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2020
- Study start13 Feb 2020
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
- Investigators
- Ronald Goldwater, Dr., Principal investigator, PAREXEL Early Phase Clinical Unit Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04269031
- Sponsor's protocol ID
- D6800C00001
- Status last verified
- Jul 2023
- First submitted
- 12 Feb 2020
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 request 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.
Publications
Bruggeman LA, Sedor JR, O'Toole JF. Apolipoprotein L1 and mechanisms of kidney disease susceptibility. Curr Opin Nephrol Hypertens. 2021 May 1;30(3):317-323. doi: 10.1097/MNH.0000000000000704.
PubMed 33767059
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, First-in-Human, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2373 Following Single Ascending Dose Administrations to Healthy Male Subjects of African Ancestry
- ClinicalTrials.gov ID
- NCT04269031
- Acronym / sponsor ID
- D6800C00001
- Conditions
- Healthy Volunteers
- Keywords
- First-in-Human, Randomized, Single-blind, Placebo controlled, AZD2373, Single Ascending Dose, Sentinel Dosing
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 13 Feb 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 13 Feb 2020 (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 is a Phase 1 study to assess the the safety, tolerability and pharmacokinetics (PK) of AZD2373, following subcutaneous (SC) administration of single ascending doses (SAD) of AZD2373 in healthy male subjects of African ancestry.
Detailed description
This study will be conducted as a single-centre, randomised, placebo-controlled, single-blind study to assess the effect of AZD2373 following ascending dose sequential group design administrations to healthy male subjects of African ancestry. The study will include 6 single dose cohorts with the option to include 2 additional cohorts based on emerging data from preceding cohorts in the study.
Approximately 48 male subjects aged 18 to 55 years at the time of informed consent (inclusive) will be randomized with the aim to have 8 subjects participate in each cohort. Within each cohort, 6 subjects will receive AZD2373 and 2 subjects will receive placebo.
Sentinel dosing will be applied for each cohort and will be divided into 2 groups:
- Group 1 (sentinel group): 1 active, 1 placebo;
- Group 2 (the rest of the cohort): 5 active, 1 placebo. The safety data of up to 72 hours post-dose in Group 1 will be reviewed by the Principal Investigator (PI) before the subjects in Group 2 are dosed.
The study will comprise:
- A Screening Period of maximum 35 days;
- A Treatment Period during which subjects will be resident at the Clinical Unit from the day before investigational medicinal product (IMP) administration (Day -1) until at least 72 hours after IMP administration; discharged from the Clinical Unit on Day 4;
- Follow-up Visits on 1, 1.5, 2, 3, 4, 5, 6, and 8 weeks (Visits 3 to 10); and
- A Final Follow up Visit 10 weeks after the last IMP dose.
The visit occurring at 5 weeks post dose (Visit 5) is optional. The expected duration for any subject participating in the study is approximately 10 weeks (excluding an up to 28-day Screening Period).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: AZD2373 subcutaneous injection, Drug: PlaceboOn Day 1, randomized subjects will receive a subcutaneous (SC) injection of AZD2373 dose 1 (6 subjects) or matching placebo (2 subjects). |
| Cohort 2 | Experimental | Drug: AZD2373 subcutaneous injection, Drug: PlaceboOn Day 1, randomized subjects will receive a SC injection of AZD2373 dose 2 (6 subjects) or matching placebo (2 subjects). |
| Cohort 3 | Experimental | Drug: AZD2373 subcutaneous injection, Drug: PlaceboOn Day 1, randomized subjects will receive a SC injection of AZD2373 dose 3 (6 subjects) or matching placebo (2 subjects). |
| Cohort 4 | Experimental | Drug: AZD2373 subcutaneous injection, Drug: PlaceboOn Day 1, randomized subjects will receive a SC injection of AZD2373 dose 4 (6 subjects) or matching placebo (2 subjects). |
| Cohort 5 | Experimental | Drug: AZD2373 subcutaneous injection, Drug: PlaceboOn Day 1, randomized subjects will receive a SC injection of AZD2373 dose 5 (6 subjects) or matching placebo (2 subjects). |
| Cohort 6 | Experimental | Drug: AZD2373 subcutaneous injection, Drug: PlaceboOn Day 1, randomized subjects will receive a SC injection of AZD2373 dose 6 (6 subjects) or matching placebo (2 subjects). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Healthy male subjects of West African ancestry aged 18 to 55 years (inclusive, at time of informed consent) with suitable veins for cannulation or repeated venipuncture.
- Have a body mass index (BMI) between 18 and 35 kg/m^2 (inclusive) and weigh at least 50 kg and no more than 120 kg (inclusive).
- Provision of signed, written and dated informed consent for study participation which includes mandatory genotyping (study objective). NOTE: If a subject would decline to participate in the mandatory genotyping component of the study, the subject will not be included in the study.
Key exclusion criteria (9 listed)
- Subjects with known ancestry outside of West Africa.
- History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
- 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 prior to administration of IMP on Study Day 1.
- Any laboratory values with the following deviations:
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 |
|---|---|---|
| AZD2373 subcutaneous injectionRandomised subjects will receive a single ascending dose of AZD2373 by SC injection (dose 1, dose 2, dose 3, dose 4, dose 5 and dose 6). | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6 |
| PlaceboRandomised subjects will receive a single ascending dose of placebo (saline solution) by SC injection. | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6 |
Primary outcome
Number of subjects with adverse events and/or abnormal findings in vital signs, and/or clinical laboratory assessments and/or physical examination and/or electrocardiogram (ECG) evaluation and/or telemetry and/or injection site reactions
Time frame: Screening Visit to final Follow-up Visit (Week 10 post last dose)
To assess adverse events as a variable of safety and tolerability of subcutaneous (SC) single ascending dose (SAD) administrations of AZD2373
17 secondary outcomes
Area under plasma concentration-time curve from time zero extrapolated to infinity (AUC)
Time frame: Visit 2 to final Follow-up Visit (Week 10 post last dose)
Area under the plasma concentration curve from time zero to the time of last quantifiable analyte concentration (AUClast)
Time frame: Visit 2 to final Follow-up Visit (Week 10 post last dose)
Area under the plasma concentration-time curve from time zero to 72 hours after dosing [AUC(0-72)]
Time frame: Visit 2 to final Follow-up Visit (Week 10 post last dose)
Area under the plasma concentration-time curve from time zero to 48 hours after dosing [AUC (0-48)]
Time frame: Visit 2 to final Follow-up Visit (Week 10 post last dose)
Observed maximum plasma concentration (Cmax)
Time frame: Visit 2 to final Follow-up Visit (Week 10 post last dose)
Time to reach peak or maximum observed concentration or response following drug administration (tmax)
Time frame: Visit 2 to final Follow-up Visit (Week 10 post last dose)
Half-life associated with terminal slope (λz) of a semi logarithmic concentration-time curve (t½λz)
Time frame: Visit 2 to final Follow-up Visit (Week 10 post last dose)
Apparent total body clearance of drug from plasma after extravascular administration [CL/F]
Time frame: Visit 2 to final Follow-up Visit (Week 10 post last dose)
Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)
Time frame: Visit 2 to final Follow-up Visit (Week 10 post last dose)
Mean residence time of the unchanged drug in the systemic circulation (MRT)
Time frame: Visit 2 to final Follow-up Visit (Week 10 post last dose)
Terminal elimination rate constant (λz)
Time frame: Visit 2 to final Follow-up Visit (Week 10 post last dose)
Time of the last quantifiable concentration [tlast Ae(0-last)]
Time frame: Visit 2 to final Follow-up Visit (Week 10 post last dose)
Cumulative fraction (%) of dose excreted unchanged into the urine from time zero to the last measured time point [fe(0-last)]
Time frame: Visit 2 to final Follow-up Visit (Week 10 post last dose)
Amount of analyte excreted into the urine from time t1 to t2 [Ae(t1-t2)]
Time frame: Visit 2 to final Follow-up Visit (Week 10 post last dose)
Fraction of dose excreted unchanged into the urine from time t1 to t2 [fe(t1-t2)]
Time frame: Visit 2 to final Follow-up Visit (Week 10 post last 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)
Time frame: Visit 2 to final Follow-up Visit (Week 10 post last dose)
Apolipoprotein L1 (APOL1) concentrations and change from baseline
Time frame: Visit 2 to final Follow-up Visit (Week 10 post last 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 10 Jul 2023.
- Derived from this study: PubMed 33767059Bruggeman LA, Sedor JR, O'Toole JF. Apolipoprotein L1 and mechanisms of kidney disease susceptibility. Curr Opin Nephrol Hypertens. 2021 May 1;30(3):317-323. doi: 10.1097/MNH.0000000000000704.
- 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 request 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.
Ronald Goldwater, Dr. principal investigator
PAREXEL Early Phase Clinical Unit Baltimore
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 AZD2373 subcutaneous injection in people with Healthy Volunteers, 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 4 inclusion and 9 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 10 Jul 2023. 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?
Number of subjects with adverse events and/or abnormal findings in vital signs, and/or clinical laboratory assessments and/or physical examination and/or electrocardiogram (ECG) evaluation and/or telemetry and/or injection site reactions (time frame: Screening Visit to final Follow-up Visit (Week 10 post last dose)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04269031, which also lists 1 linked publication.
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 10 Jul 2023.