AsthmaPhase 1NCT03921268
Study to Assess Effect of Device and Formulation on Pharmacokinetics (PK) of AZD1402
A Phase 1 study testing AZD1402 in people with Asthma, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
To evaluate and compare the pharmacokinetics profiles of AZD1402 after oral inhalation as an inhalation powder and a nebuliser solution. To further assess the safety and tolerability of single doses of AZD1402 in healthy volunteers. To evaluate the taste characteristics of the test formulations. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- AZD1402
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Mar 2019to 13 Jun 2019
- 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
- All sexes
- 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 and/or female subjects aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture.
- Females must have a negative pregnancy test at the Screening Visit and at Day -1 of Treatment Period 1, must not be lactating and must be of non-childbearing potential, confirmed at screening by fulfilling one of the following criteria.
- 3.1. Postmenopausal defined as amenorrhea for 2 years or more following cessation of all exogenous hormonal treatments and folliclestimulating hormone (FSH) levels in the postmenopausal range at the Screening Visit.
- 3.2. Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy.
- 3.3. Bilateral Tubal ligation at least 5 years prior to the Screening Visit with no subsequent pregnancies.
Show all 10Show fewer
- Have a body mass index (BMI) between 18 and 35 kg/m2 inclusive and weigh at least 50 kg.
- Must be able to demonstrate proper inhalation technique using the Aerosol Inhalation Monitor (AIM) device at the Screening Visit.
- Subjects must be able to perform reliable spirometry testing according to American Thoracic Society (ATS)/ European Respiratory Society (ERS) criteria at the Screening Visit.
- Provision of signed, written and dated informed consent for optional genetic research. If a subject decline to participate in the genetic component of the study, there will be no penalty or loss of benefit to the subject. The subject will not be excluded from other aspects of the study described in this protocol.
Who cannot join
- Subjects who have a significant history of recurrent or ongoing 'dry eye syndrome' of any cause that may be chronic or acute, that may affect the interpretation of safety data associated with the potential for anti-drug antibodies targeted to AZD1402 (structurally related to Tlc).
- History or clinical manifestations of any clinically significant medical disorder that, in the opinion of the Investigator, may put the subject at risk because of participation in the study, influence the results of the study or affect 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 significant illness, infection, medical/ surgical procedure, or trauma within 4 weeks of Day 1 of Treatment Period 1, or planned inpatient surgery or hospitalization during the study period.
- Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results, at the Screening Visit and/or on Day - 1 of Treatment Period 1, as judged by the PI.
- Any clinically significant abnormal findings in vital signs at the Screening Visit and/or on Day -1 of Treatment Period 1, as judged by the PI.
Show all 29Show fewer
- Any clinically significant abnormalities on 12-lead ECG at the Screening Visit., as judged by the PI.
- History of, or known significant infection including helminth, hepatitis A, B, or C, HIV, TB (i.e., positive result for interferon (INF) gamma release assay (IGRA), QuantiFERON TB-Gold), that may put the subject at risk during participation in the study.
- Subjects with history of latent or active TB.
- Subjects with any history of malignancy or neoplastic disease.
- Subjects with a disease history suggesting abnormal immune function.
- History of anaphylaxis following any biologic therapy and known history of allergy or reaction to any component of the investigational product formulation.
- Subjects who are not able to perform correct spirometry tests at the Screening Visit.
- Subjects with a forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC) < 80% of the predicted (calculated) values and FEV1/FVC ratio < 0.7 in pulmonary function test (spirometry) at the Screening Visit.
- 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 of Treatment Period 1 until 90 days after the last dose of IMP.
- Participation in any clinical study for new chemical entity within the previous 16 weeks or a marketed drug clinical study within the previous 12 weeks or within 5 half-lives whichever is the longer before the first dose of study drug. Note: subjects consented and screened, but not randomized in this study or a previous phase I study, are not excluded.
- 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
- Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the 3 months prior to the Screening Visit.
- Positive screen for drugs of abuse, alcohol or cotinine at the Screening Visit or on each admission to Clinical Unit.
- Plasma donation within 1 month of screening or any blood donation/loss more than 450 mL during the 3 months prior to the Screening Visit.
- Subjects who have received live or attenuated vaccine in the 4 weeks prior to Day 1 of Treatment Period 1.
- Use of any prescribed or non-prescribed medication including antacids, herbal remedies, megadose vitamins and minerals during the 2 weeks prior to the first administration of IMP or within 5 half-lives whichever is the longer before the first dose of study drug.
- Involvement of any AstraZeneca, PAREXEL or study site employee or their close relatives
- Subjects who have previously received AZD1402.
- Judgment by the PI that the subject 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.
- Inability to communicate well with the Investigator (i.e., language problem, poor mental development or impaired cerebral function).
- Vulnerable subjects, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order. In addition, the following is considered a criterion for the exclusion from the optional genetic component of the study
- Non-leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection or previous bone marrow transplant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Open Label, 3-period, 3-treatment, Crossover Study to Assess the Effect of Inhalation Device and Formulation on Pharmacokinetics Following a Single Inhaled Dose of AZD1402 in Healthy Subjects
To evaluate and compare the pharmacokinetics profiles of AZD1402 after oral inhalation as an inhalation powder and a nebuliser solution.
To further assess the safety and tolerability of single doses of AZD1402 in healthy volunteers.
To evaluate the taste characteristics of the test formulations.
Read the detailed description
This study will be a randomized, open-label, 3-period, 3-treatment, single dose, single-center, crossover study. Eighteen healthy male and female subjects will be randomized in this study to ensure that at least 12 subjects are evaluable. A subject will be considered to be evaluable if the subject completes all 3 Treatment Periods with no important protocol deviations. Subjects will be randomized to 1 of 6 treatment sequences and will receive each of the 3 single dose treatments of AZD1402 listed below.
- Treatment A: Dose A estimated delivered dose of AZD1402 nebuliser solution administered via a nebuliser.
- Treatment B: Dose B estimated delivered dose of AZD1402 inhalation powder administered via an inhaler.
- Treatment C: Dose C estimated delivered dose of AZD1402 inhalation powder administered via an inhaler.
The study will comprise of:
- A Screening Period of up to 28 days before the first administration of AZD1402.
- Three Treatment Periods during which subjects will be resident at the Clinical Unit from the day before dosing with AZD1402 (Day -1) until at least 48 hours after dosing and discharged on Day 3.
- A Follow-up Visit 10 to 12 days after the last administration of AZD1402 in Treatment Period 3.
Each Treatment Period will be separated by a minimum washout period of 5 days between doses.
All subjects will sign an Informed Consent Form before they participate in any specific study related procedures. Subjects will attend a Screening Visit within 28 days before receiving their first dose of AZD1402. If they are eligible, they will return for Treatment Period 1 when they will have baseline assessments and receive 1 of 3 treatments in a randomized order. For each Treatment Period, the subjects will receive a single dose of Investigational Medicinal Product (IMP) in the morning of Day 1 and have further assessments for 48 hours after dosing.
- Conditions
- Asthma
- Being tested
- AZD1402
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD1402Drug
Also called PRS-060
AZD1402 (PRS-060) is presented as a solution and dry powder for oral inhalation and belongs to a new class of therapeutics, Anticalin® proteins, which are modified lipocalins. AZD1402 is an inhaled IL-4Rα antagonist, which is being developed as controller therapy for asthma.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Dose A estimated delivered single dose of AZD1402 nebuliser solution administered via a nebuliser. Receives: Drug: AZD1402 |
| Treatment B | Experimental | Dose B estimated delivered single dose of AZD1402 inhalation powder administered via an inhaler. Receives: Drug: AZD1402 |
| Treatment C | Experimental | Dose C estimated delivered single dose of AZD1402 inhalation powder administered via an inhaler. Receives: Drug: AZD1402 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under serum concentration-time curve from zero to infinity [AUC]
To evaluate and compare the pharmacokinetics (PK) profiles of AZD1402 after oral inhalation as an inhalation powder administered using the Plastiape Monodose inhaler and a nebuliser solution administered using the InnoSpire Go nebuliser.
Measured: Pharmacokinetic Blood Sampling : Day 1: Pre-dose and 5, 20, 40minutes, and 1, 2, 3, 4, 6, 8, 12, 15 and 18 hours post-dose Day 2: 24 and 36 hours postdose. Day 3: 48 hours post-dose
Area under the serum concentration-time curve from zero to infinity divided by dose [AUC/D]
To evaluate and compare the PK profiles of AZD1402 after oral inhalation as an inhalation powder administered using the Plastiape Monodose inhaler and a nebuliser solution administered using the InnoSpire Go nebuliser.
Measured: Pharmacokinetic Blood Sampling : Day 1: Pre-dose and 5, 20, 40minutes, and 1, 2, 3, 4, 6, 8, 12, 15 and 18 hours post-dose Day 2: 24 and 36 hours postdose. Day 3: 48 hours post-dose
Area under the serum concentration-curve from time zero to time of last quantifiable concentration [AUClast]
To evaluate and compare the PK profiles of AZD1402 after oral inhalation as an inhalation powder administered using the Plastiape Monodose inhaler and a nebuliser solution administered using the InnoSpire Go nebuliser.
Measured: Pharmacokinetic Blood Sampling : Day 1: Pre-dose and 5, 20, 40minutes, and 1, 2, 3, 4, 6, 8, 12, 15 and 18 hours post-dose Day 2: 24 and 36 hours postdose. Day 3: 48 hours post-dose
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration divided by dose [AUClast/D]
To evaluate and compare the PK profiles of AZD1402 after oral inhalation as an inhalation powder administered using the Plastiape Monodose inhaler and a nebuliser solution administered using the InnoSpire Go nebuliser.
Measured: Pharmacokinetic Blood Sampling : Day 1: Pre-dose and 5, 20, 40minutes, and 1, 2, 3, 4, 6, 8, 12, 15 and 18 hours post-dose Day 2: 24 and 36 hours postdose. Day 3: 48 hours post-dose
Maximum observed serum concentration [Cmax]
To evaluate and compare the PK profiles of AZD1402 after oral inhalation as an inhalation powder administered using the Plastiape Monodose inhaler and a nebuliser solution administered using the InnoSpire Go nebuliser.
Measured: Pharmacokinetic Blood Sampling : Day 1: Pre-dose and 5, 20, 40minutes, and 1, 2, 3, 4, 6, 8, 12, 15 and 18 hours post-dose Day 2: 24 and 36 hours postdose. Day 3: 48 hours post-dose
Observed maximum serum concentration divided by the dose administered [Cmax/D]
To evaluate and compare the PK profiles of AZD1402 after oral inhalation as an inhalation powder administered using the Plastiape Monodose inhaler and a nebuliser solution administered using the InnoSpire Go nebuliser.
Measured: Pharmacokinetic Blood Sampling : Day 1: Pre-dose and 5, 20, 40minutes, and 1, 2, 3, 4, 6, 8, 12, 15 and 18 hours post-dose Day 2: 24 and 36 hours postdose. Day 3: 48 hours post-dose
Time to reach maximum observed serum concentration [tmax]
To evaluate and compare the PK profiles of AZD1402 after oral inhalation as an inhalation powder administered using the Plastiape Monodose inhaler and a nebuliser solution administered using the InnoSpire Go nebuliser.
Measured: Pharmacokinetic Blood Sampling : Day 1: Pre-dose and 5, 20, 40minutes, and 1, 2, 3, 4, 6, 8, 12, 15 and 18 hours post-dose Day 2: 24 and 36 hours postdose. Day 3: 48 hours post-dose
Terminal elimination rate constant [λz]
To evaluate and compare the PK profiles of AZD1402 after oral inhalation as an inhalation powder administered using the Plastiape Monodose inhaler and a nebuliser solution administered using the InnoSpire Go nebuliser.
Measured: Pharmacokinetic Blood Sampling : Day 1: Pre-dose and 5, 20, 40minutes, and 1, 2, 3, 4, 6, 8, 12, 15 and 18 hours post-dose Day 2: 24 and 36 hours postdose. Day 3: 48 hours post-dose
Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve [t½z]
To evaluate and compare the PK profiles of AZD1402 after oral inhalation as an inhalation powder administered using the Plastiape Monodose inhaler and a nebuliser solution administered using the InnoSpire Go nebuliser.
Measured: Pharmacokinetic Blood Sampling : Day 1: Pre-dose and 5, 20, 40minutes, and 1, 2, 3, 4, 6, 8, 12, 15 and 18 hours post-dose Day 2: 24 and 36 hours postdose. Day 3: 48 hours post-dose
Mean residence time of the unchanged drug in the systemic circulation from zero to infinity [MRT]
To evaluate and compare the PK profiles of AZD1402 after oral inhalation as an inhalation powder administered using the Plastiape Monodose inhaler and a nebuliser solution administered using the InnoSpire Go nebuliser.
Measured: Pharmacokinetic Blood Sampling : Day 1: Pre-dose and 5, 20, 40minutes, and 1, 2, 3, 4, 6, 8, 12, 15 and 18 hours post-dose Day 2: 24 and 36 hours postdose. Day 3: 48 hours post-dose
Apparent total body clearance of drug from serum after extravascular administration [CL/F]
To evaluate and compare the PK profiles of AZD1402 after oral inhalation as an inhalation powder administered using the Plastiape Monodose inhaler and a nebuliser solution administered using the InnoSpire Go nebuliser.
Measured: Pharmacokinetic Blood Sampling : Day 1: Pre-dose and 5, 20, 40minutes, and 1, 2, 3, 4, 6, 8, 12, 15 and 18 hours post-dose Day 2: 24 and 36 hours postdose. Day 3: 48 hours post-dose
Apparent volume of distribution during the terminal phase after extravascular administration [Vz/F]
To evaluate and compare the PK profiles of AZD1402 after oral inhalation as an inhalation powder administered using the Plastiape Monodose inhaler and a nebuliser solution administered using the InnoSpire Go nebuliser.
Measured: Pharmacokinetic Blood Sampling : Day 1: Pre-dose and 5, 20, 40minutes, and 1, 2, 3, 4, 6, 8, 12, 15 and 18 hours post-dose Day 2: 24 and 36 hours postdose. Day 3: 48 hours post-dose
Secondary outcomes (9)
Number of patients with adverse events
To further assess the safety and tolerability of single inhaled doses of AZD1402 in healthy volunteers.
Measured: Spontaneous plus Day 1: Pre-dose and 3 and 12 hours post-dose, Day 2: 24 hours post-dose, Day 3: 48 hours post-dose
Number of patients with abnormal findings in vital signs
To further assess the safety and tolerability of single inhaled doses of AZD1402 in healthy volunteers.
Vital signs including BP and Pulse
Measured: Day 1: Pre-dose and 10 minutes post-dose
Number of patients with abnormal electrocardiograms
To further assess the safety and tolerability of single inhaled doses of AZD1402 in healthy volunteers.
Measured: Day 1: pre-dose and 5 hours post-dose
Number of patients with abnormal physical examination
To further assess the safety and tolerability of single inhaled doses of AZD1402 in healthy volunteers.
Measured: Day 3: 48 hours post-dose (brief)
Number of patients with abnormal findings in spirometry
To further assess the safety and tolerability of single inhaled doses of AZD1402 in healthy volunteers.
Measured: Day 1: pre-dose and 0.5 and 1 hour post-dose
Number of patients with abnormal findings in hematology
To further assess the safety and tolerability of single inhaled doses of AZD1402 in healthy volunteers.
Measured: Day 3: 48 hours post-dose
Number of patients with abnormal findings in clinical chemistry
To further assess the safety and tolerability of single inhaled doses of AZD1402 in healthy volunteers.
Measured: Day 3: 48 hours post-dose
Number of patients with abnormal findings in urinalysis
To further assess the safety and tolerability of single inhaled doses of AZD1402 in healthy volunteers.
Measured: Day 3: 48 hours post-dose
Standardized taste questionnaires
To evaluate the taste characteristics of the test formulations. This will be done immediately after dosing (within 5 minutes). The taste score will be based on 6 attributes: Sweet, Salty, Sour, Bitter, Metallic and Hot/Spicy. Each attribute is with a scale of 0 to 10, where 0= "extremely low/not at all" and 10= "extremely high". If the test formulation is having a smell, another 0 to 10 scale will be there for smell with 0= "extremely bad" and 10= "extremely nice". There will be one score scale with 0="I dislike it extremely much" and 10="I like it extremely much" and another scale of taking test formulation again with 0="Never - under no circumstances" and 10= "Yes, definitely".
Measured: Day 1 to Day 3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start25 Mar 2019
- Primary completion13 Jun 2019
- Study completion13 Jun 2019
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 AsthmaStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03921268
- Sponsor's protocol ID
- D2912C00001
- Status last verified
- Jun 2019
- First submitted
- 15 Mar 2019
- Last updated
- 21 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Farrell L, Bates SM, Walker A, Ogese M, Meng X, Piper S, Mo J, Saide K, Hornberg J, Close D, Wallace I, Betts CJ, Naisbitt DJ. The immunogenic potential of AZD1402 (Elarekibep) T-cell epitopes in healthy volunteers and drug-exposed clinical trial participants. Arch Toxicol. 2026 Aug;100(8):3535-3552. doi: 10.1007/s00204-026-04403-1. Epub 2026 Apr 28.
PubMed 42050192
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Open Label, 3-period, 3-treatment, Crossover Study to Assess the Effect of Inhalation Device and Formulation on Pharmacokinetics Following a Single Inhaled Dose of AZD1402 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03921268
- Acronym / sponsor ID
- D2912C00001
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 13 Jun 2019 (actual)
- Study completion
- 13 Jun 2019 (actual)
- First posted
- 19 Apr 2019 (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.
To evaluate and compare the pharmacokinetics profiles of AZD1402 after oral inhalation as an inhalation powder and a nebuliser solution.
To further assess the safety and tolerability of single doses of AZD1402 in healthy volunteers.
To evaluate the taste characteristics of the test formulations.
Detailed description
This study will be a randomized, open-label, 3-period, 3-treatment, single dose, single-center, crossover study. Eighteen healthy male and female subjects will be randomized in this study to ensure that at least 12 subjects are evaluable. A subject will be considered to be evaluable if the subject completes all 3 Treatment Periods with no important protocol deviations. Subjects will be randomized to 1 of 6 treatment sequences and will receive each of the 3 single dose treatments of AZD1402 listed below.
- Treatment A: Dose A estimated delivered dose of AZD1402 nebuliser solution administered via a nebuliser.
- Treatment B: Dose B estimated delivered dose of AZD1402 inhalation powder administered via an inhaler.
- Treatment C: Dose C estimated delivered dose of AZD1402 inhalation powder administered via an inhaler.
The study will comprise of:
- A Screening Period of up to 28 days before the first administration of AZD1402.
- Three Treatment Periods during which subjects will be resident at the Clinical Unit from the day before dosing with AZD1402 (Day -1) until at least 48 hours after dosing and discharged on Day 3.
- A Follow-up Visit 10 to 12 days after the last administration of AZD1402 in Treatment Period 3.
Each Treatment Period will be separated by a minimum washout period of 5 days between doses.
All subjects will sign an Informed Consent Form before they participate in any specific study related procedures. Subjects will attend a Screening Visit within 28 days before receiving their first dose of AZD1402. If they are eligible, they will return for Treatment Period 1 when they will have baseline assessments and receive 1 of 3 treatments in a randomized order. For each Treatment Period, the subjects will receive a single dose of Investigational Medicinal Product (IMP) in the morning of Day 1 and have further assessments for 48 hours after dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: AZD1402Dose A estimated delivered single dose of AZD1402 nebuliser solution administered via a nebuliser. |
| Treatment B | Experimental | Drug: AZD1402Dose B estimated delivered single dose of AZD1402 inhalation powder administered via an inhaler. |
| Treatment C | Experimental | Drug: AZD1402Dose C estimated delivered single dose of AZD1402 inhalation powder administered via an inhaler. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Healthy male and/or female subjects aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture.
- Females must have a negative pregnancy test at the Screening Visit and at Day -1 of Treatment Period 1, must not be lactating and must be of non-childbearing potential, confirmed at screening by fulfilling one of the following criteria.
- 3.1. Postmenopausal defined as amenorrhea for 2 years or more following cessation of all exogenous hormonal treatments and folliclestimulating hormone (FSH) levels in the postmenopausal range at the Screening Visit.
- 3.2. Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy.
Key exclusion criteria (29 listed)
- Subjects who have a significant history of recurrent or ongoing 'dry eye syndrome' of any cause that may be chronic or acute, that may affect the interpretation of safety data associated with the potential for anti-drug antibodies targeted to AZD1402 (structurally related to Tlc).
- History or clinical manifestations of any clinically significant medical disorder that, in the opinion of the Investigator, may put the subject at risk because of participation in the study, influence the results of the study or affect 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 significant illness, infection, medical/ surgical procedure, or trauma within 4 weeks of Day 1 of Treatment Period 1, or planned inpatient surgery or hospitalization during the study period.
- Any clinically significant abnormalities in clinical chemistry, hematology, or urinalysis results, at the Screening Visit and/or on Day - 1 of Treatment Period 1, as judged by the PI.
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 |
|---|---|---|
| AZD1402Also: PRS-060AZD1402 (PRS-060) is presented as a solution and dry powder for oral inhalation and belongs to a new class of therapeutics, Anticalin® proteins, which are modified lipocalins. AZD1402 is an inhaled IL-4Rα antagonist, which is being developed as controller therapy for asthma. | Drug | Treatment A, Treatment B, Treatment C |
Primary outcome
Area under serum concentration-time curve from zero to infinity [AUC]
Time frame: Pharmacokinetic Blood Sampling : Day 1: Pre-dose and 5, 20, 40minutes, and 1, 2, 3, 4, 6, 8, 12, 15 and 18 hours post-dose Day 2: 24 and 36 hours postdose. Day 3: 48 hours post-dose
To evaluate and compare the pharmacokinetics (PK) profiles of AZD1402 after oral inhalation as an inhalation powder administered using the Plastiape Monodose inhaler and a nebuliser solution administered using the InnoSpire Go nebuliser.
Area under the serum concentration-time curve from zero to infinity divided by dose [AUC/D]
Time frame: Pharmacokinetic Blood Sampling : Day 1: Pre-dose and 5, 20, 40minutes, and 1, 2, 3, 4, 6, 8, 12, 15 and 18 hours post-dose Day 2: 24 and 36 hours postdose. Day 3: 48 hours post-dose
To evaluate and compare the PK profiles of AZD1402 after oral inhalation as an inhalation powder administered using the Plastiape Monodose inhaler and a nebuliser solution administered using the InnoSpire Go nebuliser.
Area under the serum concentration-curve from time zero to time of last quantifiable concentration [AUClast]
Time frame: Pharmacokinetic Blood Sampling : Day 1: Pre-dose and 5, 20, 40minutes, and 1, 2, 3, 4, 6, 8, 12, 15 and 18 hours post-dose Day 2: 24 and 36 hours postdose. Day 3: 48 hours post-dose
To evaluate and compare the PK profiles of AZD1402 after oral inhalation as an inhalation powder administered using the Plastiape Monodose inhaler and a nebuliser solution administered using the InnoSpire Go nebuliser.
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration divided by dose [AUClast/D]
Time frame: Pharmacokinetic Blood Sampling : Day 1: Pre-dose and 5, 20, 40minutes, and 1, 2, 3, 4, 6, 8, 12, 15 and 18 hours post-dose Day 2: 24 and 36 hours postdose. Day 3: 48 hours post-dose
To evaluate and compare the PK profiles of AZD1402 after oral inhalation as an inhalation powder administered using the Plastiape Monodose inhaler and a nebuliser solution administered using the InnoSpire Go nebuliser.
Maximum observed serum concentration [Cmax]
Time frame: Pharmacokinetic Blood Sampling : Day 1: Pre-dose and 5, 20, 40minutes, and 1, 2, 3, 4, 6, 8, 12, 15 and 18 hours post-dose Day 2: 24 and 36 hours postdose. Day 3: 48 hours post-dose
To evaluate and compare the PK profiles of AZD1402 after oral inhalation as an inhalation powder administered using the Plastiape Monodose inhaler and a nebuliser solution administered using the InnoSpire Go nebuliser.
Observed maximum serum concentration divided by the dose administered [Cmax/D]
Time frame: Pharmacokinetic Blood Sampling : Day 1: Pre-dose and 5, 20, 40minutes, and 1, 2, 3, 4, 6, 8, 12, 15 and 18 hours post-dose Day 2: 24 and 36 hours postdose. Day 3: 48 hours post-dose
To evaluate and compare the PK profiles of AZD1402 after oral inhalation as an inhalation powder administered using the Plastiape Monodose inhaler and a nebuliser solution administered using the InnoSpire Go nebuliser.
Time to reach maximum observed serum concentration [tmax]
Time frame: Pharmacokinetic Blood Sampling : Day 1: Pre-dose and 5, 20, 40minutes, and 1, 2, 3, 4, 6, 8, 12, 15 and 18 hours post-dose Day 2: 24 and 36 hours postdose. Day 3: 48 hours post-dose
To evaluate and compare the PK profiles of AZD1402 after oral inhalation as an inhalation powder administered using the Plastiape Monodose inhaler and a nebuliser solution administered using the InnoSpire Go nebuliser.
Terminal elimination rate constant [λz]
Time frame: Pharmacokinetic Blood Sampling : Day 1: Pre-dose and 5, 20, 40minutes, and 1, 2, 3, 4, 6, 8, 12, 15 and 18 hours post-dose Day 2: 24 and 36 hours postdose. Day 3: 48 hours post-dose
To evaluate and compare the PK profiles of AZD1402 after oral inhalation as an inhalation powder administered using the Plastiape Monodose inhaler and a nebuliser solution administered using the InnoSpire Go nebuliser.
Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve [t½z]
Time frame: Pharmacokinetic Blood Sampling : Day 1: Pre-dose and 5, 20, 40minutes, and 1, 2, 3, 4, 6, 8, 12, 15 and 18 hours post-dose Day 2: 24 and 36 hours postdose. Day 3: 48 hours post-dose
To evaluate and compare the PK profiles of AZD1402 after oral inhalation as an inhalation powder administered using the Plastiape Monodose inhaler and a nebuliser solution administered using the InnoSpire Go nebuliser.
Mean residence time of the unchanged drug in the systemic circulation from zero to infinity [MRT]
Time frame: Pharmacokinetic Blood Sampling : Day 1: Pre-dose and 5, 20, 40minutes, and 1, 2, 3, 4, 6, 8, 12, 15 and 18 hours post-dose Day 2: 24 and 36 hours postdose. Day 3: 48 hours post-dose
To evaluate and compare the PK profiles of AZD1402 after oral inhalation as an inhalation powder administered using the Plastiape Monodose inhaler and a nebuliser solution administered using the InnoSpire Go nebuliser.
Apparent total body clearance of drug from serum after extravascular administration [CL/F]
Time frame: Pharmacokinetic Blood Sampling : Day 1: Pre-dose and 5, 20, 40minutes, and 1, 2, 3, 4, 6, 8, 12, 15 and 18 hours post-dose Day 2: 24 and 36 hours postdose. Day 3: 48 hours post-dose
To evaluate and compare the PK profiles of AZD1402 after oral inhalation as an inhalation powder administered using the Plastiape Monodose inhaler and a nebuliser solution administered using the InnoSpire Go nebuliser.
Apparent volume of distribution during the terminal phase after extravascular administration [Vz/F]
Time frame: Pharmacokinetic Blood Sampling : Day 1: Pre-dose and 5, 20, 40minutes, and 1, 2, 3, 4, 6, 8, 12, 15 and 18 hours post-dose Day 2: 24 and 36 hours postdose. Day 3: 48 hours post-dose
To evaluate and compare the PK profiles of AZD1402 after oral inhalation as an inhalation powder administered using the Plastiape Monodose inhaler and a nebuliser solution administered using the InnoSpire Go nebuliser.
9 secondary outcomes
Number of patients with adverse events
Time frame: Spontaneous plus Day 1: Pre-dose and 3 and 12 hours post-dose, Day 2: 24 hours post-dose, Day 3: 48 hours post-dose
Number of patients with abnormal findings in vital signs
Time frame: Day 1: Pre-dose and 10 minutes post-dose
Number of patients with abnormal electrocardiograms
Time frame: Day 1: pre-dose and 5 hours post-dose
Number of patients with abnormal physical examination
Time frame: Day 3: 48 hours post-dose (brief)
Number of patients with abnormal findings in spirometry
Time frame: Day 1: pre-dose and 0.5 and 1 hour post-dose
Number of patients with abnormal findings in hematology
Time frame: Day 3: 48 hours post-dose
Number of patients with abnormal findings in clinical chemistry
Time frame: Day 3: 48 hours post-dose
Number of patients with abnormal findings in urinalysis
Time frame: Day 3: 48 hours post-dose
Standardized taste questionnaires
Time frame: Day 1 to Day 3.
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 21 Jun 2019.
- Derived from this study: PubMed 42050192Farrell L, Bates SM, Walker A, Ogese M, Meng X, Piper S, Mo J, Saide K, Hornberg J, Close D, Wallace I, Betts CJ, Naisbitt DJ. The immunogenic potential of AZD1402 (Elarekibep) T-cell epitopes in healthy volunteers and drug-exposed clinical trial participants. Arch Toxicol. 2026 Aug;100(8):3535-3552. doi: 10.1007/s00204-026-04403-1. Epub 2026 Apr 28.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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 AZD1402 in people with 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 10 inclusion and 29 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 21 Jun 2019. 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 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?
Area under serum concentration-time curve from zero to infinity [AUC] (time frame: Pharmacokinetic Blood Sampling : Day 1: Pre-dose and 5, 20, 40minutes, and 1, 2, 3, 4, 6, 8, 12, 15 and 18 hours post-dose Day 2: 24 and 36 hours postdose. Day 3: 48 hours post-dose). The study lists 12 primary outcomes in all. 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 NCT03921268, 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 21 Jun 2019.