Healthy Subjects (Indication: Asthma)Phase 1NCT05794672
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Elarekibep in Healthy Japanese Subjects
A Phase 1 study testing Elarekibep in people with Healthy Subjects (Indication: Asthma), run by AstraZeneca at 1 site in United Kingdom.
Trial summary
This study will assess the safety, tolerability and pharmacokinetics (PK) of elarekibep after single and multiple doses given twice daily (BID) by inhalation or intravenous (IV) in healthy Japanese subjects compared with placebo. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Healthy Subjects (Indication: Asthma)
- What is being tested?
- Elarekibep
- 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 Kingdom
- Study dates
- 11 Apr 2023to 8 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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subject must be aged 20 to 55 years.
- Subject must have a Body Mass Index (BMI) between 18 and 35 kg/m2 and weigh a minimum of 48 kg.
- First generation subjects who were born in Japan and who have both parents and grandparents of Japanese descent.
- All females must have a negative pregnancy test at the Screening Visit (serum) and on admission (urine) to the Clinical Unit and must not be lactating or planning to become pregnant.
- Subjects who are non-smokers or ex-smokers who have smoked no more than twice in the 3 months preceding the first dose of study drug.
- Must be able to demonstrate proper inhalation technique using the monodose Dry Powder Inhaler (DPI) device.
- Able to perform acceptable pulmonary function testing for Forced Expiratory Volume in one second (FEV1) according to American Thoracic Society (ATS)/European Respiratory Society (ERS) acceptability criteria.
Who cannot join
- History or clinical manifestations of any clinically significant medical disorder which may either put the subject at risk because of participation in the study, influence the results, or affect the subject's ability to participate in the study.
- History or presence of gastrointestinal, hepatic or renal disease.
- Any clinically significant illness, infection, medical/surgical procedure, or trauma within 4 weeks of Day 1 or planned in-patient surgery or hospitalization during the study period.
- Diagnosis of Sjögren's syndrome.
- Any laboratory values with deviations from the study's laboratory parameters.
- Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV).
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- Any clinically important abnormalities in rhythm, conduction or morphology of the resting Electrocardiogram (ECG) and any clinically important abnormalities in the 12 lead ECG.
- Known or suspected history of drug abuse in the last 5 years.
- Known or suspected history of alcohol abuse or excessive intake of alcohol in the last 2 years.
- Positive screen for drugs of abuse, alcohol or cotinine at the Screening Visit.
- History of anaphylaxis following any biologic therapy or vaccine and known history of allergy or reaction to any component of the Investigational Medicinal Product (IMP) formulation.
- Plasma donation within 1 month of the Screening Visit or any blood donation/blood loss > 450 mL during the 3 months prior to the Screening Visit.
- Excessive intake of caffeine containing drinks or food.
- Participation in more than 4 clinical studies with IMPs in the last year.
- Involvement of subjects who have a significant history of recurrent or ongoing dry eye syndrome of any cause that may be chronic or acute and that may affect the interpretation of safety data associated with the potential for ADAs targeted to elarekibep.
- Subjects with a positive diagnostic nucleic acid test (using Polymerase Chain Reaction [PCR]) and/or rapid antigen test for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) at screening and up to randomisation.
- Diagnosis of/suspected COVID-19 infection with associated pneumonia/pneumonitis.
- Receipt of COVID-19 vaccine (vaccine or booster dose) within 30 days prior to randomisation.
- History of anaphylaxis to any biologic therapy or vaccine.
- History of hypersensitivity that required the use of epinephrine or hospitalization.
- Known history of allergy or reaction to any component of the IMP formulation.
- History of allergic conjunctivitis and/or dry eye syndrome.
- Clinically significant lower respiratory tract infection not resolved within 4 weeks prior to screening.
- History of cancer within the last 10 years except for basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix treated and considered cured. Any history of lymphoma is not allowed.
- Males who are sexually active with a female partner of childbearing potential and who have not had a vasectomy and who do not agree to comply with highly effective methods of contraception from Day 1 until 90 days after the last dose of IMP.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomised, Single-blind, Placebo-controlled, Single-centre Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of Elarekibep Given Twice Daily as Inhaled or a Single IV Formulation in Healthy Japanese Subjects
This study will assess the safety, tolerability and pharmacokinetics (PK) of elarekibep after single and multiple doses given twice daily (BID) by inhalation or intravenous (IV) in healthy Japanese subjects compared with placebo.
Read the detailed description
This is a Phase I, randomised, single-blind, placebo-controlled, single-centre study. This study comprises upto a total of 42 subjects.
This study consists of two parts: A single dose part (Part A1 and Part A2) and a multiple dose part (Part B).
Part A and Part B will comprise of the following:
- Each subject will be involved in the study for up to 9 weeks if enrolled in Part A and up to 10 weeks if enrolled in Part B.
- A screening period of maximum 28 days.
- Treatment period: Part A: Study treatment Day 1; Part B: Study treatment Days 1 to 6 and a single inhaled dose on Day 7.
- A safety follow-up call will be conducted 7 (± 1) days after elarekibep or placebo administration.
- A safety follow-up visit will be conducted 30 (± 2) days after elarekibep or placebo administration in each cohort.
- Conditions
- Healthy Subjects (Indication: Asthma)
- Being tested
- Elarekibep, Placebo
- Keywords
- Heterogenous respiratory disease, Pulmonary inflammation, Healthy subjects, Japanese subjects, Interleukin 4 receptor alpha antagonist
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElarekibepDrug
Also called AZD1402
Subjects will receive single or multiple inhaled doses A, B or C, or single IV dose D of elarekibep.
PlaceboDrug
Subjects will receive single or multiple inhaled doses A, B or C.
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Part A1: Each subject in three of the single inhaled dose cohorts will receive a single inhaled dose A, B, or C elarekibep and placebo in the fourth cohort.
Part A2: Each subject will receive a single Intravenous (IV) dose D elarekibep in one cohort. Receives: Drug: Elarekibep; Drug: Placebo |
| Part B | Experimental | Each subject will receive multiple inhaled doses C elarekibep or placebo twice daily (BID) for 6 days in the first cohort and a single inhaled dose on Day 7 in the second cohort. Receives: Drug: Elarekibep; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse events
The safety and tolerability of elarekibep after single and multiple inhaled or single Intravenous (IV) dose administrations in healthy Japanese subjects will be assessed.
Measured: Up to Follow-up [Part A: 60 days, Part B: 67 days)
Collection of blood samples for the measurement of safety immunobiomarkers
The safety and tolerability of elarekibep after single and multiple inhaled or single Intravenous (IV) dose administrations in healthy Japanese subjects will be assessed.
Measured: Part A: Screening (Day -28) to Day 3; Part B: Screening (Day -28 to -2) to Follow-up ([Day 37 ± 2)]
Secondary outcomes (5)
Maximum observed serum (peak) drug concentration [Cmax]
The Cmax of elarekibep after single and multiple inhaled or single IV doses in healthy Japanese subjects will be evaluated.
Measured: Part A: Day 1 to Day 3, Part B: Day 1 to Day 9
Area under the serum concentration curve from zero to the last quantifiable concentration (AUClast)
The AUClast of elarekibep after single and multiple inhaled or single IV doses in healthy Japanese subjects will be evaluated.
Measured: Part A: Day 1 to Day 3, Part B: Day 1 to Day 9
Area under serum concentration time curve from zero to infinity (AUCinf)
The AUCinf of elarekibep after single and multiple inhaled or single IV doses in healthy Japanese subjects will be evaluated.
Measured: Day 1
Presence of elarekibep Antidrug Antibody (ADA)
The immunogenicity of elarekibep in healthy Japanese subjects will be evaluated.
Measured: Part A: Day 1; Part B: Day 1, Day 14 to Follow-up/ETV ([Day 37 ± 2)
Standardised taste questionnaires
Taste characteristics will be assessed within 5 minutes from dosing. There are 10 questions each of which is scored on a scale of 0 to 10 where 0 is the low range while 10 is the extreme range.
Palatability will be assessed as measured by taste scores.
Measured: Part A: Day 1, Part B: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start11 Apr 2023
- Primary completion8 Jul 2023
- Study completion8 Jul 2023
Why it stopped: This decision was based on lung findings from a non-clinical 13-week GLP toxicology study, which are not a concern for the active clinical studies but do not support long-term use and progression to later-stage development.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Subjects (Indication: Asthma)Studies 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
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 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
- NCT05794672
- Sponsor's protocol ID
- D2912C00002
- Other IDs
- 2022-000426-22
- Status last verified
- Jul 2023
- First submitted
- 20 Feb 2023
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomised, Single-blind, Placebo-controlled, Single-centre Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of Elarekibep Given Twice Daily as Inhaled or a Single IV Formulation in Healthy Japanese Subjects
- ClinicalTrials.gov ID
- NCT05794672
- Acronym / sponsor ID
- D2912C00002
- Conditions
- Healthy Subjects (Indication: Asthma)
- Keywords
- Heterogenous respiratory disease, Pulmonary inflammation, Healthy subjects, Japanese subjects, Interleukin 4 receptor alpha antagonist
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This decision was based on lung findings from a non-clinical 13-week GLP toxicology study, which are not a concern for the active clinical studies but do not support long-term use and progression to later-stage development.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- 8 Jul 2023 (actual)
- Study completion
- 8 Jul 2023 (actual)
- First posted
- 3 Apr 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.
This study will assess the safety, tolerability and pharmacokinetics (PK) of elarekibep after single and multiple doses given twice daily (BID) by inhalation or intravenous (IV) in healthy Japanese subjects compared with placebo.
Detailed description
This is a Phase I, randomised, single-blind, placebo-controlled, single-centre study. This study comprises upto a total of 42 subjects.
This study consists of two parts: A single dose part (Part A1 and Part A2) and a multiple dose part (Part B).
Part A and Part B will comprise of the following:
- Each subject will be involved in the study for up to 9 weeks if enrolled in Part A and up to 10 weeks if enrolled in Part B.
- A screening period of maximum 28 days.
- Treatment period: Part A: Study treatment Day 1; Part B: Study treatment Days 1 to 6 and a single inhaled dose on Day 7.
- A safety follow-up call will be conducted 7 (± 1) days after elarekibep or placebo administration.
- A safety follow-up visit will be conducted 30 (± 2) days after elarekibep or placebo administration in each cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: Elarekibep, Drug: PlaceboPart A1: Each subject in three of the single inhaled dose cohorts will receive a single inhaled dose A, B, or C elarekibep and placebo in the fourth cohort. Part A2: Each subject will receive a single Intravenous (IV) dose D elarekibep in one cohort. |
| Part B | Experimental | Drug: Elarekibep, Drug: PlaceboEach subject will receive multiple inhaled doses C elarekibep or placebo twice daily (BID) for 6 days in the first cohort and a single inhaled dose on Day 7 in the second cohort. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subject must be aged 20 to 55 years.
- Subject must have a Body Mass Index (BMI) between 18 and 35 kg/m2 and weigh a minimum of 48 kg.
- First generation subjects who were born in Japan and who have both parents and grandparents of Japanese descent.
- All females must have a negative pregnancy test at the Screening Visit (serum) and on admission (urine) to the Clinical Unit and must not be lactating or planning to become pregnant.
- Subjects who are non-smokers or ex-smokers who have smoked no more than twice in the 3 months preceding the first dose of study drug.
Key exclusion criteria (25 listed)
- History or clinical manifestations of any clinically significant medical disorder which may either put the subject at risk because of participation in the study, influence the results, or affect the subject's ability to participate in the study.
- History or presence of gastrointestinal, hepatic or renal disease.
- Any clinically significant illness, infection, medical/surgical procedure, or trauma within 4 weeks of Day 1 or planned in-patient surgery or hospitalization during the study period.
- Diagnosis of Sjögren's syndrome.
- Any laboratory values with deviations from the study's laboratory parameters.
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 |
|---|---|---|
| ElarekibepAlso: AZD1402Subjects will receive single or multiple inhaled doses A, B or C, or single IV dose D of elarekibep. | Drug | Part A, Part B |
| PlaceboSubjects will receive single or multiple inhaled doses A, B or C. | Drug | Part A, Part B |
Primary outcome
Incidence of Adverse events
Time frame: Up to Follow-up [Part A: 60 days, Part B: 67 days)
The safety and tolerability of elarekibep after single and multiple inhaled or single Intravenous (IV) dose administrations in healthy Japanese subjects will be assessed.
Collection of blood samples for the measurement of safety immunobiomarkers
Time frame: Part A: Screening (Day -28) to Day 3; Part B: Screening (Day -28 to -2) to Follow-up ([Day 37 ± 2)]
The safety and tolerability of elarekibep after single and multiple inhaled or single Intravenous (IV) dose administrations in healthy Japanese subjects will be assessed.
5 secondary outcomes
Maximum observed serum (peak) drug concentration [Cmax]
Time frame: Part A: Day 1 to Day 3, Part B: Day 1 to Day 9
Area under the serum concentration curve from zero to the last quantifiable concentration (AUClast)
Time frame: Part A: Day 1 to Day 3, Part B: Day 1 to Day 9
Area under serum concentration time curve from zero to infinity (AUCinf)
Time frame: Day 1
Presence of elarekibep Antidrug Antibody (ADA)
Time frame: Part A: Day 1; Part B: Day 1, Day 14 to Follow-up/ETV ([Day 37 ± 2)
Standardised taste questionnaires
Time frame: Part A: Day 1, Part B: Day 1
Results and safety
The study was stopped early (reason given: This decision was based on lung findings from a non-clinical 13-week GLP toxicology study, which are not a concern for the active clinical studies but do not support long-term use and progression to later-stage development.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- 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.
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 Elarekibep in people with Healthy Subjects (Indication: Asthma), run by AstraZeneca at 1 site in United Kingdom.
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 25 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: stopped early, as of the sponsor's last update on 18 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 Kingdom. 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 was stopped early (reason given: This decision was based on lung findings from a non-clinical 13-week GLP toxicology study, which are not a concern for the active clinical studies but do not support long-term use and progression to later-stage development.). Results are not available in the source record.
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?
Incidence of Adverse events (time frame: Up to Follow-up [Part A: 60 days, Part B: 67 days)). The study lists 2 primary outcomes in all. 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 18 Jul 2023.