Healthy VolunteersPhase 1NCT05351047
A Study to Assess Safety, Tolerability, PK and PD of AZD2373 in Healthy Male Participants of Sub-Saharan West 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 multiple ascending doses (MAD) of AZD2373 in healthy male participants of sub-Saharan West 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
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2022to 6 Jul 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 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 participants of sub-Saharan West African ancestry aged 18 to 55 years (inclusive, at time of informed consent)
- Have a BMI between 18.5 and 35 kg/m2 (inclusive) and weigh at least 50 kg and no more than 120 kg (inclusive) at screening.
- Provision of signed, written and dated informed consent and completed mandatory genotyping in the pre-screening study .
Who cannot join
- 1. Participants with known ancestry outside of sub-Saharan West Africa.
- 2. History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
- 3. History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
- 4. History of any chronic skin disease, auto-immunological diseases and allergic diseases of any etiology.
- 5. Any clinically important illness, medical/surgical procedure or trauma within 4 weeks prior to administration of IMP on Study Day 1.
- 6. Participant has clinical signs and symptoms consistent with SARS-CoV-2 or confirmed infection by appropriate laboratory test within the last 4 weeks prior to screening or on admission.
Show all 42Show fewer
- . 7. Participant who had a severe course of COVID-19.
- 8. Participant has a positive viral RNA test result for SARS-CoV-2 before randomization.
- 9. Any laboratory values with the following deviations:
- ALT or AST greater than ULN and clinically significant as determined by the PI.
- WBC count < 3.0 x 109/L.
- Hb below LLN.
- Total bilirubin > ULN.
- Platelet count below LLN.
- 10, Any clinically important abnormalities in clinical chemistry, hematology or urinalysis results, as judged by the PI.
- 11. Any positive result on Screening for serum hepatitis B surface antigen, hepatitis C antibody and HIV.
- 12. Any abnormal vital signs, after 10 minutes supine rest.
- 13. Any clinically significant abnormalities in rhythm, conduction or morphology of the resting ECG and any clinically significant abnormalities in the 12-lead ECG as considered by the Investigator that may interfere with the interpretation of QTc interval changes, including abnormal ST-T-wave morphology.
- 14. Known or suspected history of drug abuse as judged by the PI.
- 15. Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the previous 3 months.
- 16. History of alcohol abuse or excessive intake of alcohol as judged by the PI.
- 17. Positive screen for drugs of abuse or cotinine (nicotine) at Screening or admission to the Clinical Unit or positive screen for alcohol on admission to the Clinical Unit prior to administration of the IMP on Study Day 1.
- 18. History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity, as judged by the PI or history of hypersensitivity to drugs with a similar chemical structure or class to AZD2373.
- 19. Excessive intake of caffeine-containing drinks or food as judged by the PI.
- 20. Use of any prescribed or non-prescribed medication including antacids, analgesics, herbal remedies, mega-dose vitamins or minerals during the 2 weeks prior to the first administration of IMP or longer if the medication has a long t½..
- 21. Plasma donation within one month of the Screening Visit or any blood donation/blood loss > 500 mL during the 3 months prior to the Screening Visit.
- 22. Has received another new chemical entity within 3 months prior to administration of the IMP on Study Day.
- 23. Participants who have previously received AZD2373. Participants carrying a G2 allele who were enrolled in the AZD2373 SAD study but did not receive AZD2373 are not excluded.
- 24. History of severe infection, chronic or recurrent infectious disease or ongoing febrile illness within 30 days prior to Screening.
- 25. Evidence of CKD and/or proteinuria.
- 26. Blood dyscrasias with increased risk of bleeding including idiopathic thrombocytopenic purpura and thrombotic thrombocytopenic purpura or symptoms of increased risk of bleeding (frequent bleeding gums or nose bleeds).
- 27. Involvement of any AstraZeneca or Clinical Unit employee or their close relatives.
- 28. Judgment by the PI that the participant should not participate in the study if they have any ongoing or recent (i.e., during the Screening Period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions and requirements.
- 29. Participants who are vegans or have medical dietary restrictions that would make them unable to comply with the diet provided for the in-house Clinical Unit stays.
- 30. Participants who cannot communicate reliably with the PI.
- 31. Vulnerable participants, eg, kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.
- 32. History of Trypanosomiasis or Leishmaniasis.
- 33. Participants with a planned visit to a tropical or subtropical region within 10 weeks after administration of the IMP or 5 x t½ of AZD2373 (whichever is longer).
- 34. Participants with sickle cell disease will be excluded but not individuals with heterozygous sickle cell trait.
- In addition, any of the following is regarded as a criterion for exclusion from the APOL1 genotyping research (APOL1 genotyping to be assessed during the pre-screening study):
- 35. Previous bone marrow transplant.
- 36. Non-leukocyte depleted whole blood transfusion within 120 days of the date of the APOL1 genotyping sample collection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2373 Following Multiple Ascending Dose Administration to Healthy Male Participants of Sub-Saharan West African Ancestry
This is a Phase 1 study to assess the the safety, tolerability and pharmacokinetics (PK) of AZD2373, following subcutaneous (SC) administration of multiple ascending doses (MAD) of AZD2373 in healthy male participants of sub-Saharan West African ancestry.
Read the detailed description
This study will be conducted as a single center, randomized, placebo-controlled, single-blind study to assess the effect of AZD2373 following multiple ascending dose sequential group design administrations to healthy male participants of sub Saharan West African ancestry.
The study will consist of up to 5 cohorts
Up to 40 male participants aged 18 to 55 years (inclusive), at time of informed consent, will be randomized. The MAD study subjects will be selected based on the results of the pre-screening study with regards to APOL1 allele status.
For all cohorts, 8 participants will participate in each cohort.
The expected duration for any participant participating in the study is approximately 14 to 16 weeks, excluding an up to 35-day Screening Period.
- Conditions
- Healthy Volunteers
- Being tested
- AZD2373 subcutaneous injection, Placebo
- Keywords
- Phase 1, Randomized, Single-blind, Placebo controlled, AZD2373, Multiple Ascending Dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD2373 subcutaneous injectionDrug
Randomized subjects will receive multiple ascending dose of AZD2373 by SC injection (dose 1, dose 2, dose 3, dose 4, dose 5).
PlaceboDrug
Randomized subjects will receive a multiple ascending dose of placebo (saline solution) by SC injection.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Once weekly dosing for 4 weeks (Dosing Days 1, 8, 15 and 22) OR Once weekly dosing for 6 weeks (Dosing Days 1, 8, 15, 22, 29 and 36) 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 | Once weekly for 6 weeks dosing on Days 1, 8, 15, 22, 29 and 36 randomized subjects will receive a subcutaneous (SC) injection of AZD2373 dose 2 (6 subjects) or matching placebo (2 subjects). Receives: Drug: AZD2373 subcutaneous injection; Drug: Placebo |
| Cohort 3 | Experimental | Three times weekly for 6 weeks dosing each week on Days 1, 3, and 5 randomized subjects will receive a subcutaneous (SC) injection of AZD2373 dose 3 (6 subjects) or matching placebo (2 subjects). Receives: Drug: AZD2373 subcutaneous injection; Drug: Placebo |
| Cohort 4 (optional) | Experimental | Between one to seven doses each week for 6 weeks randomized subjects will receive a subcutaneous (SC) injection of AZD2373 dose 4 (6 subjects) or matching placebo (2 subjects). Receives: Drug: AZD2373 subcutaneous injection; Drug: Placebo |
| Cohort 5 (optional) | Experimental | Between one to seven doses each week for 6 weeks randomized subjects will receive a subcutaneous (SC) injection of AZD2373 dose 5 (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 injection site reactions
To assess the safety and tolerability of subcutaneous (SC) multiple ascending dose (MAD) administrations of AZD2373.
Measured: Up to 21 weeks (From Screening to Final Visit)
Secondary outcomes (8)
AUCinf
To characterize the PK of AZD2373 following SC MAD administrations of AZD2373
Measured: Up to 16 weeks (From Visit 2 to Final Visit)
AUCt
To characterize the PK of AZD2373 following SC MAD administrations of AZD2373
Measured: Up to 16 weeks (From Visit 2 to Final Visit)
AUCτ
To characterize the PK of AZD2373 following SC MAD administrations of AZD2373
Measured: Up to 16 weeks (From Visit 2 to Final Visit)
Cmax
To characterize the PK of AZD2373 following SC MAD administrations of AZD2373
Measured: Up to 16 weeks (From Visit 2 to Final Visit)
tmax
To characterize the PK of AZD2373 following SC MAD administrations of AZD2373
Measured: Up to 16 weeks (From Visit 2 to Final Visit)
t1/2
To characterize the PK of AZD2373 following SC MAD administrations of AZD2373
Measured: Up to 16 weeks (From Visit 2 to Final Visit)
Percent change in plasma APOL1 protein from baseline
To assess the effect of SC MAD administrations of AZD2373 on plasma concentrations of APOL1 protein
Measured: Up to 21 weeks (From Screening to Final Visit)
APOL1 allele status
To determine APOL1 G0, G1, G2 allele genotype status in all study participants
Measured: Days -35 to -1 (Screening period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start4 Apr 2022
- Primary completion6 Jul 2023
- Study completion6 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05351047
- Sponsor's protocol ID
- D6800C00002
- Status last verified
- Aug 2023
- First submitted
- 1 Apr 2022
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2373 Following Multiple Ascending Dose Administration to Healthy Male Participants of Sub-Saharan West African Ancestry
- ClinicalTrials.gov ID
- NCT05351047
- Acronym / sponsor ID
- D6800C00002
- Conditions
- Healthy Volunteers
- Keywords
- Phase 1, Randomized, Single-blind, Placebo controlled, AZD2373, Multiple Ascending Dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 6 Jul 2023 (actual)
- Study completion
- 6 Jul 2023 (actual)
- First posted
- 28 Apr 2022 (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 multiple ascending doses (MAD) of AZD2373 in healthy male participants of sub-Saharan West African ancestry.
Detailed description
This study will be conducted as a single center, randomized, placebo-controlled, single-blind study to assess the effect of AZD2373 following multiple ascending dose sequential group design administrations to healthy male participants of sub Saharan West African ancestry.
The study will consist of up to 5 cohorts
Up to 40 male participants aged 18 to 55 years (inclusive), at time of informed consent, will be randomized. The MAD study subjects will be selected based on the results of the pre-screening study with regards to APOL1 allele status.
For all cohorts, 8 participants will participate in each cohort.
The expected duration for any participant participating in the study is approximately 14 to 16 weeks, excluding an up to 35-day Screening Period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: AZD2373 subcutaneous injection, Drug: PlaceboOnce weekly dosing for 4 weeks (Dosing Days 1, 8, 15 and 22) OR Once weekly dosing for 6 weeks (Dosing Days 1, 8, 15, 22, 29 and 36) 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: PlaceboOnce weekly for 6 weeks dosing on Days 1, 8, 15, 22, 29 and 36 randomized subjects will receive a subcutaneous (SC) injection of AZD2373 dose 2 (6 subjects) or matching placebo (2 subjects). |
| Cohort 3 | Experimental | Drug: AZD2373 subcutaneous injection, Drug: PlaceboThree times weekly for 6 weeks dosing each week on Days 1, 3, and 5 randomized subjects will receive a subcutaneous (SC) injection of AZD2373 dose 3 (6 subjects) or matching placebo (2 subjects). |
| Cohort 4 (optional) | Experimental | Drug: AZD2373 subcutaneous injection, Drug: PlaceboBetween one to seven doses each week for 6 weeks randomized subjects will receive a subcutaneous (SC) injection of AZD2373 dose 4 (6 subjects) or matching placebo (2 subjects). |
| Cohort 5 (optional) | Experimental | Drug: AZD2373 subcutaneous injection, Drug: PlaceboBetween one to seven doses each week for 6 weeks randomized subjects will receive a subcutaneous (SC) injection of AZD2373 dose 5 (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 participants of sub-Saharan West African ancestry aged 18 to 55 years (inclusive, at time of informed consent)
- Have a BMI between 18.5 and 35 kg/m2 (inclusive) and weigh at least 50 kg and no more than 120 kg (inclusive) at screening.
- Provision of signed, written and dated informed consent and completed mandatory genotyping in the pre-screening study .
Key exclusion criteria (42 listed)
- 1. Participants with known ancestry outside of sub-Saharan West Africa.
- 2. History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
- 3. History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs.
- 4. History of any chronic skin disease, auto-immunological diseases and allergic diseases of any etiology.
- 5. Any clinically important illness, medical/surgical procedure or trauma within 4 weeks prior to administration of IMP on Study Day 1.
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 injectionRandomized subjects will receive multiple ascending dose of AZD2373 by SC injection (dose 1, dose 2, dose 3, dose 4, dose 5). | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 (optional), Cohort 5 (optional) |
| PlaceboRandomized subjects will receive a multiple ascending dose of placebo (saline solution) by SC injection. | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 (optional), Cohort 5 (optional) |
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 injection site reactions
Time frame: Up to 21 weeks (From Screening to Final Visit)
To assess the safety and tolerability of subcutaneous (SC) multiple ascending dose (MAD) administrations of AZD2373.
8 secondary outcomes
AUCinf
Time frame: Up to 16 weeks (From Visit 2 to Final Visit)
AUCt
Time frame: Up to 16 weeks (From Visit 2 to Final Visit)
AUCτ
Time frame: Up to 16 weeks (From Visit 2 to Final Visit)
Cmax
Time frame: Up to 16 weeks (From Visit 2 to Final Visit)
tmax
Time frame: Up to 16 weeks (From Visit 2 to Final Visit)
t1/2
Time frame: Up to 16 weeks (From Visit 2 to Final Visit)
Percent change in plasma APOL1 protein from baseline
Time frame: Up to 21 weeks (From Screening to Final Visit)
APOL1 allele status
Time frame: Days -35 to -1 (Screening period)
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 7 Aug 2023.
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Pain
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 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 42 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 7 Aug 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 injection site reactions (time frame: Up to 21 weeks (From Screening to Final 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 7 Aug 2023.