Home › Trials › NCT06732882

Evaluating a new asthma medication using inhalers in adults

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

Phase 1 Interventional AstraZeneca · NCT06732882

This study is testing a new asthma medication given through inhalers to see if it is safe and effective for adults with mild asthma.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment28 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Locations11 sites (Berlin and 10 other locations)
Trial IDNCT06732882 on ClinicalTrials.gov

What this trial studies

This study investigates the pharmacokinetics and pharmacodynamics of AZD4604, a Janus Kinase 1 inhibitor, administered via Turbuhaler and Genuair devices in adults with mild asthma. It is a multicenter, randomized, placebo-controlled, single-blind trial where participants will receive either the medication or a placebo over a 10-day period. The study aims to assess the safety, tolerability, and effects on fractional exhaled nitric oxide (FeNO) levels. Participants will be monitored throughout the study duration of 58 days.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with physician-diagnosed mild asthma and elevated FeNO levels.

Not a fit: Patients with severe asthma or those not meeting the specific inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for patients with mild asthma.

How similar studies have performed: Other studies have shown promise with similar pharmacological approaches, but this specific combination is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Berlin and 10 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions AsthmaTurbuhaler deviceGenuair deviceJanus Kinase 1 inhibitor
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.