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

Last updated: March 28, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

1

Condition

Asthma

Treatment

Turbuhaler

Genuair

Placebo

Clinical Study ID

NCT06732882
D8210C00006
2024-516474-30-00
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Main Inclusion Criteria:

  • Participant must be 18 to 65 years of age inclusive with suitable veins forcannulation or repeated venepuncture.

  • Participants must have Physician-diagnosed mild asthma for at least 6 months priorto 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 andon admission to the clinical site or prior to randomisation and must not belactating. However, there are no restrictions on male participants or their femalepartners.

  • Contraceptive use by females should be consistent with local regulations regardingthe methods of contraception for those participating in clinical studies.

  • Capable of giving signed and dated informed consent prior to any study-specificprocedure.

Exclusion

Main Exclusion Criteria:

  • History of any clinically important disease or disorder which, in the opinion of thePrincipal Investigator (PI), may either put the participant at risk because ofparticipation in the study, or influence the results or the participant's ability toparticipate in the study.

  • History of cancer within the last 10 years (20 years for breast cancer) except forbasal and squamous cell carcinoma of the skin or in situ carcinoma of the cervixtreated and considered cured. Any history of lymphoma is not allowed and diseasehistory 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 othercondition known to interfere with absorption, distribution, metabolism, or excretionof drugs.

  • Any clinically important illness, medical/surgical procedure, or trauma within 4weeks of the first administration of the study intervention.

  • History of serious or severe adverse reaction or known hypersensitivity to AZD4604or any of its additive constituents

  • High sensitivity C-reactive protein > Upper Limit of Normal (ULN) at Screening Visitand Baseline/Run-in Period.

  • Any clinically important abnormalities in clinical chemistry, haematology orurinalysis results as judged by the PI. The PI may consider appropriate ethnicityadjusted 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 importantallergy/hypersensitivity, as judged by the PI or history of hypersensitivity todrugs with a similar chemical structure or class to AZD4604.

  • Use of drugs with enzyme-inducing properties such as St John's wort within 3 weeksprior 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/bloodloss > 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 theresting Electrocardiogram (ECG) and any clinically important abnormalities in the 12-lead ECG as considered by the investigator that may interfere with theinterpretation of QTc interval changes.

  • Female participants who are planning a pregnancy during the study period or withinone month after the last dose of study intervention.

  • Exacerbation of asthma symptoms within 6 months prior to Screening Visit and Day -1requiring the use of oral, IM or IV steroids, antibiotics, accident and emergencyvisit, or hospital admission.

  • If in the judgement of the PI, the participant has any ongoing or recent (ie, duringthe Screening Period) minor medical complaints that may interfere with theinterpretation of study data or are considered unlikely to comply with studyprocedures, restrictions, and requirements, the participant should not be enrolled.

  • Has received another new chemical entity (defined as a compound which has not beenapproved for marketing) within 3 months of the first administration of studyintervention in this study.

Study Design

Total Participants: 28
Treatment Group(s): 4
Primary Treatment: Turbuhaler
Phase: 1
Study Start date:
February 27, 2025
Estimated Completion Date:
September 17, 2025

Study 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.

Connect with a study center

  • Research Site

    Berlin, 10119
    Germany

    Active - Recruiting

  • Research Site

    Frankfurt, 60596
    Germany

    Active - Recruiting

  • Research Site

    Großhansdorf, 22927
    Germany

    Active - Recruiting

  • Research Site

    Hannover, 30625
    Germany

    Site Not Available

  • Research Site

    Lübeck, 23552
    Germany

    Active - Recruiting

  • Research Site

    Cambridge, CB2 0AY
    United Kingdom

    Active - Recruiting

  • Research Site

    Harrow, HA1 3UJ
    United Kingdom

    Active - Recruiting

  • Research Site

    Liverpool, L7 8XP
    United Kingdom

    Active - Recruiting

  • Research Site

    London, N12 8BU
    United Kingdom

    Active - Recruiting

  • Research Site

    Wythenshawe, M23 9QZ
    United Kingdom

    Active - Recruiting

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