Study to Evaluate the Pharmacokinetics and Pharmacodynamics of AZD4604 Given Via the Turbuhaler® Device in Adults With Mild Asthma.
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
2 other identifiers
interventional
28
2 countries
10
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 asthma
Started Feb 2025
Shorter than P25 for phase_1 asthma
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2024
CompletedFirst Posted
Study publicly available on registry
December 13, 2024
CompletedStudy Start
First participant enrolled
February 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 29, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 29, 2025
CompletedJune 5, 2025
June 1, 2025
3 months
December 10, 2024
June 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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.
Day 9 (Pre-dose) and Day 10 (Pre-dose and Post-dose)
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.
Day 9 (Pre-dose) and Day 10 (Pre-dose and Post-dose)
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.
Day 9 (Pre-dose) and Day 10 (Pre-dose and Post-dose)
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.
Day 10 (Pre-dose and Post-dose)
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.
Day 10 (Pre-dose and Post-dose)
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.
Day 9 (Pre-dose) and Day 10 (Pre-dose and Post-dose)
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.
Day 9 (Pre-dose) and Day 10 (Pre-dose and Post-dose)
Secondary Outcomes (12)
Change from baseline to end of treatment in FeNO levels
From Screening visit (Day -42 to Day -3), Day -2 to Day 4, Day 9 to Day 10, Follow-up visit (Day 16)
Percentage of participants who achieve a FeNO < 25 ppb Cmax/D
From Screening visit (Day -42 to Day -3), Day -2 to Day 4, Day 9 to Day 10, Follow-up visit (Day 16)
Change from baseline to end of treatment in FeNO levels
From Screening visit (Day -42 to Day -3), Day -2 to Day 4, Day 9 to Day 10, Follow-up visit (Day 16)
Maximum observed drug concentration (Cmax) of AZD4604
Day 9 and Day 10
Time to reach maximum observed concentration (tmax) of AZD4604
Day 9 and Day 10
- +7 more secondary outcomes
Study Arms (5)
AZD4604 dose A via Genuair
EXPERIMENTALParticipants will receive dose A of AZD4604 via Genuair device twice daily
AZD4604 dose A via Turbuhaler
EXPERIMENTALParticipants will receive dose A of AZD4604 via Turbuhaler device twice daily
AZD4604 dose B via Turbuhaler
EXPERIMENTALParticipants will receive dose B of AZD4604 via Turbuhaler device twice daily
Placebo via Genuair
PLACEBO COMPARATORParticipants will receive placebo via Genuair device twice daily
Placebo via Turbuhaler
PLACEBO COMPARATORParticipants will receive placebo via Turbuhaler device twice daily
Interventions
Participants will receive AZD4604 via Genuair/Turbuhaler device.
Participants will receive placebo via Genuair/Turbuhaler device.
Participants will either receive AZD4604 or placebo via Genuair device.
Participants will receive either AZD4604 or placebo via Turbuhaler device.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (10)
Research Site
Berlin, 10119, Germany
Research Site
Berlin, 10787, Germany
Research Site
Frankfurt, 60596, Germany
Research Site
Großhansdorf, 22927, Germany
Research Site
Lübeck, 23552, Germany
Research Site
Cambridge, CB2 0AY, United Kingdom
Research Site
Harrow, HA1 3UJ, United Kingdom
Research Site
Liverpool, L7 8XP, United Kingdom
Research Site
London, N12 8BU, United Kingdom
Research Site
Wythenshawe, M23 9QZ, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2024
First Posted
December 13, 2024
Study Start
February 27, 2025
Primary Completion
May 29, 2025
Study Completion
May 29, 2025
Last Updated
June 5, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environmentVivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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.