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.
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
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
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 group | Role | What they receive |
|---|---|---|
| AZD4604 dose A via Genuair | Experimental | Participants will receive dose A of AZD4604 via Genuair device twice daily Receives: Drug: AZD4604; Device: Genuair |
| AZD4604 dose A via Turbuhaler | Experimental | Participants will receive dose A of AZD4604 via Turbuhaler device twice daily Receives: Drug: AZD4604; Device: Turbuhaler |
| AZD4604 dose B via Turbuhaler | Experimental | Participants will receive dose B of AZD4604 via Turbuhaler device twice daily Receives: Drug: AZD4604; Device: Turbuhaler |
| Placebo via Genuair | Placebo comparator | Participants will receive placebo via Genuair device twice daily Receives: Other: Placebo; Device: Genuair |
| Placebo via Turbuhaler | Placebo comparator | Participants 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.
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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
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
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
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
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
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
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
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
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.
- First posted13 Dec 2024
- Study start27 Feb 2025
- Primary completion29 May 2025
- Study completion29 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06732882
- Acronym / sponsor ID
- D8210C00006
- Conditions
- Asthma
- Keywords
- Turbuhaler device, Genuair device, Janus Kinase 1 inhibitor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2025 (actual)
- Primary completion
- 29 May 2025 (actual)
- Study completion
- 29 May 2025 (actual)
- First posted
- 13 Dec 2024 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| AZD4604 dose A via Genuair | Experimental | Drug: AZD4604, Device: GenuairParticipants will receive dose A of AZD4604 via Genuair device twice daily |
| AZD4604 dose A via Turbuhaler | Experimental | Drug: AZD4604, Device: TurbuhalerParticipants will receive dose A of AZD4604 via Turbuhaler device twice daily |
| AZD4604 dose B via Turbuhaler | Experimental | Drug: AZD4604, Device: TurbuhalerParticipants will receive dose B of AZD4604 via Turbuhaler device twice daily |
| Placebo via Genuair | Placebo comparator | Other: Placebo, Device: GenuairParticipants will receive placebo via Genuair device twice daily |
| Placebo via Turbuhaler | Placebo comparator | Other: Placebo, Device: TurbuhalerParticipants will receive placebo via Turbuhaler device twice daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| AZD4604Participants will receive AZD4604 via Genuair/Turbuhaler device. | Drug | AZD4604 dose A via Genuair, AZD4604 dose A via Turbuhaler, AZD4604 dose B via Turbuhaler |
| PlaceboParticipants will receive placebo via Genuair/Turbuhaler device. | Other | Placebo via Genuair, Placebo via Turbuhaler |
| GenuairParticipants will either receive AZD4604 or placebo via Genuair device. | Device | AZD4604 dose A via Genuair, Placebo via Genuair |
| TurbuhalerParticipants will receive either AZD4604 or placebo via Turbuhaler device. | Device | AZD4604 dose A via Turbuhaler, AZD4604 dose B via Turbuhaler, Placebo via Turbuhaler |
Primary outcome
Maximum observed drug concentration (Cmax) of AZD4604
Time frame: Day 9 (Pre-dose) and Day 10 (Pre-dose and Post-dose)
The Cmax of AZD4604 at Day 10 of dosing with dose A and dose B when delivered by the Turbuhaler device will be characterised.
Time to reach maximum observed concentration (tmax) of AZD4604
Time frame: Day 9 (Pre-dose) and Day 10 (Pre-dose and Post-dose)
The tmax of AZD4604 at Day 10 of dosing with dose A and dose B when delivered by the Turbuhaler device will be characterised.
Area under concentration-time curve in the dosing interval (AUCtau) of AZD4604
Time frame: Day 9 (Pre-dose) and Day 10 (Pre-dose and Post-dose)
The AUCtau of AZD4604 at Day 10 of dosing with dose A and dose B when delivered by the Turbuhaler device will be characterised.
Apparent total body clearance (CL/F) of AZD4604
Time frame: Day 10 (Pre-dose and Post-dose)
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.
Apparent volume of distribution based on the terminal phase (VZ/F) of AZD4604
Time frame: Day 10 (Pre-dose and Post-dose)
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.
Dose normalised AUCtau (AUCtau/D) of AZD4604
Time frame: Day 9 (Pre-dose) and Day 10 (Pre-dose and Post-dose)
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.
Dose normalised Cmax (Cmax/D) of AZD4604
Time frame: Day 9 (Pre-dose) and Day 10 (Pre-dose and Post-dose)
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.
12 secondary outcomes
Change from baseline to end of treatment in FeNO levels
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 9 and Day 10
Time to reach maximum observed concentration (tmax) of AZD4604
Time frame: Day 9 and Day 10
Area under concentration-time curve in the dosing interval (AUCtau) of AZD4604
Time frame: Day 9 and Day 10
Apparent total body clearance (CL/F) of AZD4604
Time frame: Day 10
Apparent volume of distribution based on the terminal phase (VZ/F)
Time frame: Day 10
Dose normalised AUCtau (AUCtau/D) of AZD4604
Time frame: Day 9 and Day 10
Dose normalised Cmax (Cmax/D) of AZD4604
Time frame: Day 9 and Day 10
Maximum observed drug concentration (Cmax) of AZD4604
Time frame: Day 9 and Day 10
Area under concentration-time curve in the dosing interval (AUCtau)
Time frame: Day 9 and Day 10
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 5 Jun 2025.
- Individual participant dataSharing planned: 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.
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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.
10 sites in 2 countries: see every site and its status.
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.