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AsthmaPhase 1NCT06732882

Study to Evaluate the Pharmacokinetics and Pharmacodynamics of AZD4604 Given Via the Turbuhaler® Device in Adults With Mild Asthma.

A Phase 1 study testing AZD4604, Genuair and Turbuhaler in people with Asthma, run by AstraZeneca at 10 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study will investigate the Pharmacokinetic (PK), Pharmacodynamic (PD), the safety and tolerability of AZD4604, as well as to examine the effect of Fractional exhaled Nitric Oxide (FeNO) following the administration of the multiple doses of AZD4604 via Turbuhaler device. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Asthma
What is being tested?
AZD4604, Genuair and Turbuhaler
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
28 participants
Where
10 sitesin 2 countries
Study dates
27 Feb 2025to 29 May 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Main Inclusion Criteria:

  • Participant must be 18 to 65 years of age inclusive with suitable veins for cannulation or repeated venepuncture.
  • Participants must have Physician-diagnosed mild asthma for at least 6 months prior to Screening Visit.
  • ≥ 70% predicted for FEV1 at the Screening Visit AND on Day -1.
  • Have a FeNO of ≥ 40 ppb at the Screening Visit and on Day -2.
  • Body weight at least 50 kg and BMI within the range 18 to 35 kg/m2 (inclusive).
  • Female participants must have a negative pregnancy test at the Screening Visit and on admission to the clinical site or prior to randomisation and must not be lactating. However, there are no restrictions on male participants or their female partners.
  • Contraceptive use by females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Capable of giving signed and dated informed consent prior to any study-specific procedure.

Main Exclusion Criteria:

  • History of any clinically important disease or disorder which, in the opinion of the Principal Investigator (PI), 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.
  • History of cancer within the last 10 years (20 years for breast cancer) 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 and disease history suggesting abnormal immune function.
  • Participants with increased risk of infection.
  • Have received any vaccine in the 30 days prior to the first dose.
  • History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
  • Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of the study intervention.
  • History of serious or severe adverse reaction or known hypersensitivity to AZD4604 or any of its additive constituents
  • High sensitivity C-reactive protein > Upper Limit of Normal (ULN) at Screening Visit and Baseline/Run-in Period.
  • Any clinically important abnormalities in clinical chemistry, haematology or urinalysis results as judged by the PI. The PI may consider appropriate ethnicity adjusted local reference ranges for haematology or clinical chemistry measurements, when available.
  • Known or suspected history of drug abuse as judged by the PI and current smokers.
  • 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 AZD4604.
  • Use of drugs with enzyme-inducing properties such as St John's wort within 3 weeks prior to the first administration of study intervention.
  • History of alcohol abuse or excessive intake of alcohol as judged by the PI.
  • 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.
  • Participants who cannot communicate reliably with the PI or vulnerable participants.
  • Any clinically important abnormalities in rhythm, conduction or morphology of the resting Electrocardiogram (ECG) and any clinically important abnormalities in the 12-lead ECG as considered by the investigator that may interfere with the interpretation of QTc interval changes.
  • Female participants who are planning a pregnancy during the study period or within one month after the last dose of study intervention.
  • Exacerbation of asthma symptoms within 6 months prior to Screening Visit and Day -1 requiring the use of oral, IM or IV steroids, antibiotics, accident and emergency visit, or hospital admission.
  • If in the judgement of the PI, the participant has any ongoing or recent (ie, 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, the participant should not be enrolled.
  • Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 3 months of the first administration of study intervention in this study.

Trial locations and contacts

10 sites in 2 countries.

10 sites in 2 countries

Germany5 sites
  • Research Site

    Berlin, 10119

  • Research Site

    Berlin, 10787

  • Research Site

    Frankfurt, 60596

  • Research Site

    Großhansdorf, 22927

  • Research Site

    Lübeck, 23552

Other trials in Germany

United Kingdom5 sites
  • Research Site

    Cambridge, CB2 0AY

  • Research Site

    Harrow, HA1 3UJ

  • Research Site

    Liverpool, L7 8XP

  • Research Site

    London, N12 8BU

  • Research Site

    Wythenshawe, M23 9QZ

Other trials in United Kingdom

About this study

Official title: A Phase Ib, Multicentre, Randomised, Single-blind, Parallel-group, Placebo-controlled, Study to Characterise the Pharmacokinetics and Pharmacodynamics of AZD4604 Administered Via the Turbuhaler® Device in Adults With Mild Asthma

The study will investigate the Pharmacokinetic (PK), Pharmacodynamic (PD), the safety and tolerability of AZD4604, as well as to examine the effect of Fractional exhaled Nitric Oxide (FeNO) following the administration of the multiple doses of AZD4604 via Turbuhaler device.

Read the detailed description

This is a multicentre, randomised, placebo-controlled, single-blind study to characterise PK and PD of AZD4604, administered twice daily (BID) using a Turbuhaler or a Genuair device.

Participants who have mild asthma with a raised FeNO will be randomised into the study to evaluate AZD4604 versus placebo, at 2 dose levels delivered via: a) the Turbuhaler device and b) the Genuair device.

The study will be comprised of:

  • A screening period (Day -42 to Day-3)
  • Participants will be randomised to one of 5 treatment arms where participants will either receive BID doses of AZD4604 or placebo from Day 1 to Day 9 and a single dose on Day 10.
  • A follow-up Visit on Day 16

The total duration of the study will be for 58 days.

Conditions
Asthma
Being tested
AZD4604, Placebo, Genuair, Turbuhaler
Keywords
Turbuhaler device, Genuair device, Janus Kinase 1 inhibitor
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AZD4604Drug

    Participants will receive AZD4604 via Genuair/Turbuhaler device.

  • PlaceboOther

    Participants will receive placebo via Genuair/Turbuhaler device.

  • GenuairDevice

    Participants will either receive AZD4604 or placebo via Genuair device.

  • TurbuhalerDevice

    Participants will receive either AZD4604 or placebo via Turbuhaler device.

Study groups in NCT06732882
Study groupRoleWhat they receive
AZD4604 dose A via GenuairExperimentalParticipants will receive dose A of AZD4604 via Genuair device twice daily
Receives: Drug: AZD4604; Device: Genuair
AZD4604 dose A via TurbuhalerExperimentalParticipants will receive dose A of AZD4604 via Turbuhaler device twice daily
Receives: Drug: AZD4604; Device: Turbuhaler
AZD4604 dose B via TurbuhalerExperimentalParticipants will receive dose B of AZD4604 via Turbuhaler device twice daily
Receives: Drug: AZD4604; Device: Turbuhaler
Placebo via GenuairPlacebo comparatorParticipants will receive placebo via Genuair device twice daily
Receives: Other: Placebo; Device: Genuair
Placebo via TurbuhalerPlacebo comparatorParticipants will receive placebo via Turbuhaler device twice daily
Receives: Other: Placebo; Device: Turbuhaler

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum observed drug concentration (Cmax) of AZD4604

    The Cmax of AZD4604 at Day 10 of dosing with dose A and dose B when delivered by the Turbuhaler device will be characterised.

    Measured: Day 9 (Pre-dose) and Day 10 (Pre-dose and Post-dose)

  2. Time to reach maximum observed concentration (tmax) of AZD4604

    The tmax of AZD4604 at Day 10 of dosing with dose A and dose B when delivered by the Turbuhaler device will be characterised.

    Measured: Day 9 (Pre-dose) and Day 10 (Pre-dose and Post-dose)

  3. Area under concentration-time curve in the dosing interval (AUCtau) of AZD4604

    The AUCtau of AZD4604 at Day 10 of dosing with dose A and dose B when delivered by the Turbuhaler device will be characterised.

    Measured: Day 9 (Pre-dose) and Day 10 (Pre-dose and Post-dose)

  4. Apparent total body clearance (CL/F) of AZD4604

    The CL/F of AZD4604 at Day 10 of dosing with dose A and dose B when delivered by the Turbuhaler device will be characterised.

    Measured: Day 10 (Pre-dose and Post-dose)

  5. Apparent volume of distribution based on the terminal phase (VZ/F) of AZD4604

    The VZ/F of AZD4604 at Day 10 of dosing with dose A and dose B when delivered by the Turbuhaler device will be characterised.

    Measured: Day 10 (Pre-dose and Post-dose)

  6. Dose normalised AUCtau (AUCtau/D) of AZD4604

    The AUCtau/D of AZD4604 at Day 10 of dosing with dose A and dose B when delivered by the Turbuhaler device will be characterised.

    Measured: Day 9 (Pre-dose) and Day 10 (Pre-dose and Post-dose)

  7. Dose normalised Cmax (Cmax/D) of AZD4604

    The Cmax/D of AZD4604 at Day 10 of dosing with dose A and dose B when delivered by the Turbuhaler device will be characterised.

    Measured: Day 9 (Pre-dose) and Day 10 (Pre-dose and Post-dose)

Secondary outcomes (12)
  1. Change from baseline to end of treatment in FeNO levels

    The change in FeNO levels from baseline to end of treatment after administration of AZD4604 delivered via Turbuhaler device will be evaluated.

    Measured: From Screening visit (Day -42 to Day -3), Day -2 to Day 4, Day 9 to Day 10, Follow-up visit (Day 16)

  2. Percentage of participants who achieve a FeNO < 25 ppb Cmax/D

    The percentage of participants who achieve a FeNO <25 ppb after administration of AZD4604 delivered via Turbuhaler device will be evaluated.

    Measured: From Screening visit (Day -42 to Day -3), Day -2 to Day 4, Day 9 to Day 10, Follow-up visit (Day 16)

  3. Change from baseline to end of treatment in FeNO levels

    The change in FeNO levels from baseline to end of treatment after administration of AZD4604 delivered via Turbuhaler and Genuair devices will be evaluated.

    Measured: From Screening visit (Day -42 to Day -3), Day -2 to Day 4, Day 9 to Day 10, Follow-up visit (Day 16)

  4. Maximum observed drug concentration (Cmax) of AZD4604

    The Cmax of AZD4604 at Day 10 of dosing with dose A, when delivered by the Genuair device will be characterised.

    Measured: Day 9 and Day 10

  5. Time to reach maximum observed concentration (tmax) of AZD4604

    The tmax of AZD4604 at Day 10 of dosing with dose A, when delivered by the Genuair device will be characterised.

    Measured: Day 9 and Day 10

  6. Area under concentration-time curve in the dosing interval (AUCtau) of AZD4604

    The AUCtau of AZD4604 at Day 10 of dosing with dose A, when delivered by the Genuair device will be characterised.

    Measured: Day 9 and Day 10

  7. Apparent total body clearance (CL/F) of AZD4604

    The CL/F of AZD4604 at Day 10 of dosing with dose A, when delivered by the Genuair device will be characterised.

    Measured: Day 10

  8. Apparent volume of distribution based on the terminal phase (VZ/F)

    The VZ/F of AZD4604 at Day 10 of dosing with dose A, when delivered by the Genuair device will be characterised.

    Measured: Day 10

  9. Dose normalised AUCtau (AUCtau/D) of AZD4604

    The AUCtau/D of AZD4604 at Day 10 of dosing with dose A, when delivered by the Genuair device will be characterised.

    Measured: Day 9 and Day 10

  10. Dose normalised Cmax (Cmax/D) of AZD4604

    The Cmax/D of AZD4604 at Day 10 of dosing with dose A, when delivered by the Genuair device will be characterised.

    Measured: Day 9 and Day 10

  11. Maximum observed drug concentration (Cmax) of AZD4604

    The Cmax of AZD4604 at Day 10 of dosing with dose A is compared via the Turbuhaler and Genuair devices.

    Measured: Day 9 and Day 10

  12. Area under concentration-time curve in the dosing interval (AUCtau)

    The AUCtau of AZD4604 at Day 10 of dosing with dose A is compared via the Turbuhaler and Genuair devices.

    Measured: Day 9 and Day 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2024
  2. Study start27 Feb 2025
  3. Primary completion29 May 2025
  4. Study completion29 May 2025

Resources

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
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06732882
Sponsor's protocol ID
D8210C00006
Other IDs
2024-516474-30-00
Status last verified
Jun 2025
First submitted
10 Dec 2024
Last updated
5 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
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 Vivli.org. 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 approved.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AZD4604, Genuair and Turbuhaler in people with Asthma, run by AstraZeneca at 10 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Germany, 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum observed drug concentration (Cmax) of AZD4604 (time frame: Day 9 (Pre-dose) and Day 10 (Pre-dose and Post-dose)). The study lists 7 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 5 Jun 2025.

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