Healthy ParticipantsPhase 1NCT06519968
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Inhaled AZD4604 in Healthy Japanese and Chinese Participants.
A Phase 1 study testing AZD4604 in people with Healthy Participants, run by AstraZeneca at 1 site in United Kingdom.
Trial summary
The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics (PK) of AZD4604 when administered as single or multiple inhaled doses to healthy Japanese and Chinese participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- AZD4604
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jul 2024to 27 Dec 2024
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Japanese participants who are born in Japan, has 2 Japanese biological parents, 4 Japanese grandparents as confirmed by the interview and has lived outside Japan for less than 10 years at the time of screening.
- Chinese participants who are born in China, has 2 Chinese biological parents, 4 Chinese grandparents as confirmed by the interview and has lived outside China for less than 10 years at the time of screening.
- Have body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 45 kg.
- Healthy participants must have a Forced Expiratory Volume at first breath (FEV1) ≥ 80% of the predicted value in accordance with American Thoracic Society (ATS)/European Respiratory Society (ERS) criteria at the Screening and admission visits.
- Female participants must have a negative pregnancy test.
Who cannot join
- History or presence of clinically important disease which may put participant at risk because of participation in study.
- Participant has an increased risk of infection.
- History of malignancy other than superficial basal cell carcinoma, having a first degree relative with lung cancer or disease history suggesting abnormal immune function.
- Has received any vaccine 30 days prior to first dose.
- Has a body temperature of > 37.7°C on Day -1.
- History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
Show all 16Show fewer
- Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of study intervention.
- Known or suspected history of drug abuse, alcohol abuse or excessive intake of alcohol.
- Current smokers or those who have smoked or used nicotine products (including e-cigarettes, vaping, and nicotine replacement therapy) within the previous 6 months or has a smoking history of > 5 pack-years.
- History of a serious or severe adverse reaction to AZD4604 or any of its additive constituents.
- History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity or history of hypersensitivity to drugs with a similar chemical structure or class to AZD4604.
- Plasma donation within 1 month of the Screening Visit or any blood donation/blood loss> 500 mL during the 3 months prior to the Screening Visit.
- Any clinically important abnormalities in rhythm, conduction or morphology of the resting electrocardiogram (ECG) and any clinically important abnormalities in the 12-lead safety ECG.
- Female participants who are planning a pregnancy during the study period or within 1 month after the last dose of study intervention.
- Abnormal vital signs at the Screening Visit, after 5 minutes supine rest.
- History of any significant respiratory disorders such as asthma (a history of childhood asthma without symptoms or treatment after the age of 10 years is allowable), chronic obstructive pulmonary disease, or idiopathic pulmonary fibrosis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-blind, Randomised, Placebo-controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Inhaled AZD4604 Following Single Ascending and Multiple Doses in Healthy Japanese and Chinese Participants
The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics (PK) of AZD4604 when administered as single or multiple inhaled doses to healthy Japanese and Chinese participants.
Read the detailed description
This study will comprise of two parts: Part 1 and Part 2
Part 1 will investigate the safety, tolerability, and PK of inhaled AZD4604 following single ascending and multiple doses in healthy Japanese participants.
Part 1a will include three single ascending dose (SAD) cohorts and Part 1b will include one multiple dose cohort.
Part 2 will investigate the safety, tolerability, and PK of inhaled AZD4604 following single ascending and multiple doses in healthy Chinese participants.
Part 2a will include two SAD cohort and Part 2b will include one multiple dose cohort.
Part 1a and Part 2a will comprise of:
- A Screening Visit within 28 days before dosing.
- A treatment period (Day 1 to Day 7)
- A final assessment on Day 7
Part 1b and Part 2b will comprise of:
- A Screening Visit within 28 days before dosing.
- A treatment period (Day 1 to Day 13)
- A final assessment on Day 13
- Conditions
- Healthy Participants
- Being tested
- AZD4604, Placebo
- Keywords
- Ascending doses, Multiple doses, JAK1 inhibitor, Chinese, Japanese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD4604Drug
AZD4604 will be administered as Dry Powder Inhalation (DPI).
PlaceboDrug
Placebo will be administered as DPI.
| Study group | Role | What they receive |
|---|---|---|
| Part 1a: AZD4604 (Dose 1) SAD | Experimental | Japanese participants will receive single dose of AZD4604 (Dose 1) via inhalation on Day 1. Receives: Drug: AZD4604 |
| Part 1a: AZD4604 (Dose 2) SAD | Experimental | Japanese participants will receive single dose of AZD4604 (Dose 2) via inhalation on Day 1. Receives: Drug: AZD4604 |
| Part 1a: AZD4604 (Dose 3) SAD | Experimental | Japanese participants will receive single dose of AZD4604 (Dose 3) via inhalation on Day 1. Receives: Drug: AZD4604 |
| Part 1a: Placebo | Placebo comparator | Japanese participants will receive single dose of matching placebo to AZD4604 on Day 1. Receives: Drug: Placebo |
| Part 1b: AZD4604 (Dose 4) Multiple dose cohort | Experimental | Japanese participants will receive AZD4604 (Dose 4) via inhalation twice daily (BID) from Day 1 to Day 6 and a single dose on Day 7. Receives: Drug: AZD4604 |
| Part 1b: Placebo | Placebo comparator | Japanese participants will receive matching placebo to AZD4604 BID from day 1 to day 6 and a single dose of placebo on Day 7. Receives: Drug: Placebo |
| Part 2a: AZD4604 (Dose 1) SAD | Experimental | Chinese participants will receive single dose of AZD4604 (Dose 1) via inhalation on Day 1. Receives: Drug: AZD4604 |
| Part 2a: AZD4604 (Dose 3) SAD | Experimental | Chinese participants will receive single dose of AZD4604 (Dose 3) via inhalation on Day 1. Receives: Drug: AZD4604 |
| Part 2a: Placebo | Placebo comparator | Chinese participants will receive single dose of matching placebo to AZD4604 on Day 1. Receives: Drug: Placebo |
| Part 2 b: AZD4604 (Dose 4) Multiple dose cohort | Experimental | Chinese participants will receive AZD4604 (Dose 4) via inhalation BID from Day 1 to Day 6 and a single dose on Day 7. Receives: Drug: AZD4604 |
| Part 2b: Placebo | Placebo comparator | Chinese participants will receive placebo via inhalation BID from Day 1 to Day 6 and a single dose on Day 7. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse event (AEs)
To assess the safety and tolerability of AZD4604 following inhaled administration of AZD4604 as single ascending doses (Parts 1a and 2a), and multiple doses (Parts 1b and 2b).
Measured: From Day -28 to 5 weeks (Parts 1a and 2a); Day -28 to 6 weeks (Parts 1b and 2b)
Secondary outcomes (17)
Maximum observed plasma (peak) drug concentration (Cmax)
To characterise the plasma PK of AZD4604 following inhaled administration of AZD4604 as single ascending doses (Parts 1a and 2a), and multiple doses (Parts 1b and 2b).
Measured: From Day 1 to Day 7 (Parts 1a and 2a); From Day 1 to Day 13 (Parts 1b and 2b)
Time to reach peak or maximum observed concentration following drug administration (tmax)
To characterise the plasma PK of AZD4604 following inhaled administration of AZD4604 as single ascending doses (Parts 1a and 2a), and multiple doses (Parts 1b and 2b).
Measured: From Day 1 to Day 7 (Parts 1a and 2a); From Day 1 to Day 13 (Parts 1b and 2b)
Terminal elimination rate constant (λz)
To characterise the plasma PK of AZD4604 following inhaled administration of AZD4604 as single ascending doses (Parts 1a and 2a), and multiple doses (Parts 1b and 2b).
Measured: From Day 1 to Day 7 (Parts 1a and 2a); From Day 1 to Day 13 (Parts 1b and 2b)
Half-life associated with terminal slope of a semi-logarithmic concentration time curve (t½λz)
To characterise the plasma PK of AZD4604 following inhaled administration of AZD4604 as single ascending doses (Parts 1a and 2a), and multiple doses (Parts 1b and 2b).
Measured: From Day 1 to Day 7 (Parts 1a and 2a); From Day 1 to Day 13 (Parts 1b and 2b)
Partial area under concentration-time curve from time 0 to 12 hours (AUC [0-12])
To characterise the plasma PK of AZD4604 following inhaled administration of AZD4604 as single ascending doses (Parts 1a and 2a), and multiple doses (Parts 1b and 2b).
Measured: From Day 1 to Day 7 (Parts 1a and 2a); On Day 1 (Parts 1b and 2b)
Partial area under concentration-time curve from time 0 to 24 hours (AUC [0-24])
To characterise the plasma PK of AZD4604 following inhaled administration of AZD4604 as single ascending doses (Parts 1a and 2a), and multiple doses (Parts 1b and 2b).
Measured: From Day 1 to Day 7 (Parts 1a and 2a); From Day 1 to Day 13 (Parts 1b and 2b)
Area under the plasma concentration curve from zero to last quantifiable concentration (AUClast)
To characterise the plasma PK of AZD4604 following inhaled administration of AZD4604 as single ascending doses (Parts 1a and 2a), and multiple doses (Parts 1b and 2b).
Measured: From Day 1 to Day 7 (Parts 1a and 2a); From Day 1 to Day 13 (Parts 1b and 2b)
Area under the plasma concentration curve from zero to infinity (AUCinf)
To characterise the plasma PK of AZD4604 following inhaled administration of AZD4604 as single ascending doses (Parts 1a and 2a).
Measured: From Day 1 to Day 7 (Parts 1a and 2a)
Apparent total body clearance of drug from plasma after extravascular administration (CL/F)
To characterise the plasma PK of AZD4604 following inhaled administration of AZD4604 as single ascending doses (Parts 1a and 2a), and multiple doses (Parts 1b and 2b).
Measured: From Day 1 to Day 7 (Parts 1a and 2a); From Day 1 to Day 13 (Parts 1b and 2b)
Volume of distribution (apparent) at steady state following extravascular administration based on terminal phase (Vz/F)
To characterise the plasma PK of AZD4604 following inhaled administration of AZD4604 as single ascending doses (Parts 1a and 2a), and multiple doses (Parts 1b and 2b).
Measured: From Day 1 to Day 7 (Parts 1a and 2a); From Day 1 to Day 13 (Parts 1b and 2b)
Area under the plasma concentration time curve from zero to the last quantifiable concentration, divided by dose (AUClast/D)
To characterise the plasma PK of AZD4604 following inhaled administration of AZD4604 as single ascending doses (Parts 1a and 2a), and multiple doses (Parts 1b and 2b).
Measured: From Day 1 to Day 7 (Parts 1a and 2a); From Day 1 to Day 13 (Parts 1b and 2b)
Area under the plasma concentration curve from zero to infinity, divided by dose (AUCinf/D)
To characterise the plasma PK of AZD4604 following inhaled administration of AZD4604 as single ascending doses (Parts 1a and 2a).
Measured: From Day 1 to Day 7 (Parts 1a and 2a)
Maximum observed plasma (peak) drug concentration, by dose (Cmax/D)
To characterise the plasma PK of AZD4604 following inhaled administration of AZD4604 as single ascending doses (Parts 1a and 2a), and multiple doses (Parts 1b and 2b).
Measured: From Day 1 to Day 7 (Parts 1a and 2a); From Day 1 to Day 13 (Parts 1b and 2b)
The last time point at which the concentration is measured (tlast)
To characterise the plasma PK of AZD4604 following inhaled administration of AZD4604 as single ascending doses (Parts 1a and 2a), and multiple doses (Parts 1b and 2b).
Measured: From Day 1 to Day 7 (Parts 1a and 2a); From Day 1 to Day 13 (Parts 1b and 2b)
Area under plasma concentration time curve from zero to end of dosing interval (AUCτ)
To characterise the plasma PK of AZD4604 following inhaled administration of AZD4604 as multiple doses (Parts 1b and 2b).
Measured: From Day 1 to Day 13 (Parts 1b and 2b)
Area under plasma concentration time curve from zero to end of dosing interval, by dose (AUCτ/D)
To characterise the plasma PK of AZD4604 following inhaled administration of AZD4604 as multiple doses (Parts 1b and 2b).
Measured: From Day 1 to Day 13 (Parts 1b to 2b)
Cough Severity self-assessment as measured by Visual Analogue Scale (VAS)
The cough VAS is a brief and simple measure of cough severity. It consists of a 100 mm vertical scale on which the participant is asked to place a cross at the point that indicates the severity of his/her cough in the last 24 hours between "No cough" and "Worst cough ever". The position of the cross is measured from the "No cough" reference point. A minimal clinically important difference is considered to be a 17 mm change from previous.
Measured: From Day 1 to Day 8 (Parts 1b and 2b)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start15 Jul 2024
- Primary completion27 Dec 2024
- Study completion27 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06519968
- Sponsor's protocol ID
- D8210C00002
- Status last verified
- Nov 2025
- First submitted
- 5 Jul 2024
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- 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 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-blind, Randomised, Placebo-controlled Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Inhaled AZD4604 Following Single Ascending and Multiple Doses in Healthy Japanese and Chinese Participants
- ClinicalTrials.gov ID
- NCT06519968
- Acronym / sponsor ID
- D8210C00002
- Conditions
- Healthy Participants
- Keywords
- Ascending doses, Multiple doses, JAK1 inhibitor, Chinese, Japanese
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 15 Jul 2024 (actual)
- Primary completion
- 27 Dec 2024 (actual)
- Study completion
- 27 Dec 2024 (actual)
- First posted
- 25 Jul 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 purpose of this study is to investigate the safety, tolerability, and pharmacokinetics (PK) of AZD4604 when administered as single or multiple inhaled doses to healthy Japanese and Chinese participants.
Detailed description
This study will comprise of two parts: Part 1 and Part 2
Part 1 will investigate the safety, tolerability, and PK of inhaled AZD4604 following single ascending and multiple doses in healthy Japanese participants.
Part 1a will include three single ascending dose (SAD) cohorts and Part 1b will include one multiple dose cohort.
Part 2 will investigate the safety, tolerability, and PK of inhaled AZD4604 following single ascending and multiple doses in healthy Chinese participants.
Part 2a will include two SAD cohort and Part 2b will include one multiple dose cohort.
Part 1a and Part 2a will comprise of:
- A Screening Visit within 28 days before dosing.
- A treatment period (Day 1 to Day 7)
- A final assessment on Day 7
Part 1b and Part 2b will comprise of:
- A Screening Visit within 28 days before dosing.
- A treatment period (Day 1 to Day 13)
- A final assessment on Day 13
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Part 1a: AZD4604 (Dose 1) SAD | Experimental | Drug: AZD4604Japanese participants will receive single dose of AZD4604 (Dose 1) via inhalation on Day 1. |
| Part 1a: AZD4604 (Dose 2) SAD | Experimental | Drug: AZD4604Japanese participants will receive single dose of AZD4604 (Dose 2) via inhalation on Day 1. |
| Part 1a: AZD4604 (Dose 3) SAD | Experimental | Drug: AZD4604Japanese participants will receive single dose of AZD4604 (Dose 3) via inhalation on Day 1. |
| Part 1a: Placebo | Placebo comparator | Drug: PlaceboJapanese participants will receive single dose of matching placebo to AZD4604 on Day 1. |
| Part 1b: AZD4604 (Dose 4) Multiple dose cohort | Experimental | Drug: AZD4604Japanese participants will receive AZD4604 (Dose 4) via inhalation twice daily (BID) from Day 1 to Day 6 and a single dose on Day 7. |
| Part 1b: Placebo | Placebo comparator | Drug: PlaceboJapanese participants will receive matching placebo to AZD4604 BID from day 1 to day 6 and a single dose of placebo on Day 7. |
| Part 2a: AZD4604 (Dose 1) SAD | Experimental | Drug: AZD4604Chinese participants will receive single dose of AZD4604 (Dose 1) via inhalation on Day 1. |
| Part 2a: AZD4604 (Dose 3) SAD | Experimental | Drug: AZD4604Chinese participants will receive single dose of AZD4604 (Dose 3) via inhalation on Day 1. |
| Part 2a: Placebo | Placebo comparator | Drug: PlaceboChinese participants will receive single dose of matching placebo to AZD4604 on Day 1. |
| Part 2 b: AZD4604 (Dose 4) Multiple dose cohort | Experimental | Drug: AZD4604Chinese participants will receive AZD4604 (Dose 4) via inhalation BID from Day 1 to Day 6 and a single dose on Day 7. |
| Part 2b: Placebo | Placebo comparator | Drug: PlaceboChinese participants will receive placebo via inhalation BID from Day 1 to Day 6 and a single dose on Day 7. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Japanese participants who are born in Japan, has 2 Japanese biological parents, 4 Japanese grandparents as confirmed by the interview and has lived outside Japan for less than 10 years at the time of screening.
- Chinese participants who are born in China, has 2 Chinese biological parents, 4 Chinese grandparents as confirmed by the interview and has lived outside China for less than 10 years at the time of screening.
- Have body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 45 kg.
- Healthy participants must have a Forced Expiratory Volume at first breath (FEV1) ≥ 80% of the predicted value in accordance with American Thoracic Society (ATS)/European Respiratory Society (ERS) criteria at the Screening and admission visits.
- Female participants must have a negative pregnancy test.
Key exclusion criteria (16 listed)
- History or presence of clinically important disease which may put participant at risk because of participation in study.
- Participant has an increased risk of infection.
- History of malignancy other than superficial basal cell carcinoma, having a first degree relative with lung cancer or disease history suggesting abnormal immune function.
- Has received any vaccine 30 days prior to first dose.
- Has a body temperature of > 37.7°C on Day -1.
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 |
|---|---|---|
| AZD4604AZD4604 will be administered as Dry Powder Inhalation (DPI). | Drug | Part 1a: AZD4604 (Dose 1) SAD, Part 1a: AZD4604 (Dose 2) SAD, Part 1a: AZD4604 (Dose 3) SAD, Part 1b: AZD4604 (Dose 4) Multiple dose cohort, Part 2 b: AZD4604 (Dose 4) Multiple dose cohort, Part 2a: AZD4604 (Dose 1) SAD, Part 2a: AZD4604 (Dose 3) SAD |
| PlaceboPlacebo will be administered as DPI. | Drug | Part 1a: Placebo, Part 1b: Placebo, Part 2a: Placebo, Part 2b: Placebo |
Primary outcome
Number of participants with adverse event (AEs)
Time frame: From Day -28 to 5 weeks (Parts 1a and 2a); Day -28 to 6 weeks (Parts 1b and 2b)
To assess the safety and tolerability of AZD4604 following inhaled administration of AZD4604 as single ascending doses (Parts 1a and 2a), and multiple doses (Parts 1b and 2b).
17 secondary outcomes
Maximum observed plasma (peak) drug concentration (Cmax)
Time frame: From Day 1 to Day 7 (Parts 1a and 2a); From Day 1 to Day 13 (Parts 1b and 2b)
Time to reach peak or maximum observed concentration following drug administration (tmax)
Time frame: From Day 1 to Day 7 (Parts 1a and 2a); From Day 1 to Day 13 (Parts 1b and 2b)
Terminal elimination rate constant (λz)
Time frame: From Day 1 to Day 7 (Parts 1a and 2a); From Day 1 to Day 13 (Parts 1b and 2b)
Half-life associated with terminal slope of a semi-logarithmic concentration time curve (t½λz)
Time frame: From Day 1 to Day 7 (Parts 1a and 2a); From Day 1 to Day 13 (Parts 1b and 2b)
Partial area under concentration-time curve from time 0 to 12 hours (AUC [0-12])
Time frame: From Day 1 to Day 7 (Parts 1a and 2a); On Day 1 (Parts 1b and 2b)
Partial area under concentration-time curve from time 0 to 24 hours (AUC [0-24])
Time frame: From Day 1 to Day 7 (Parts 1a and 2a); From Day 1 to Day 13 (Parts 1b and 2b)
Area under the plasma concentration curve from zero to last quantifiable concentration (AUClast)
Time frame: From Day 1 to Day 7 (Parts 1a and 2a); From Day 1 to Day 13 (Parts 1b and 2b)
Area under the plasma concentration curve from zero to infinity (AUCinf)
Time frame: From Day 1 to Day 7 (Parts 1a and 2a)
Apparent total body clearance of drug from plasma after extravascular administration (CL/F)
Time frame: From Day 1 to Day 7 (Parts 1a and 2a); From Day 1 to Day 13 (Parts 1b and 2b)
Volume of distribution (apparent) at steady state following extravascular administration based on terminal phase (Vz/F)
Time frame: From Day 1 to Day 7 (Parts 1a and 2a); From Day 1 to Day 13 (Parts 1b and 2b)
Area under the plasma concentration time curve from zero to the last quantifiable concentration, divided by dose (AUClast/D)
Time frame: From Day 1 to Day 7 (Parts 1a and 2a); From Day 1 to Day 13 (Parts 1b and 2b)
Area under the plasma concentration curve from zero to infinity, divided by dose (AUCinf/D)
Time frame: From Day 1 to Day 7 (Parts 1a and 2a)
Maximum observed plasma (peak) drug concentration, by dose (Cmax/D)
Time frame: From Day 1 to Day 7 (Parts 1a and 2a); From Day 1 to Day 13 (Parts 1b and 2b)
The last time point at which the concentration is measured (tlast)
Time frame: From Day 1 to Day 7 (Parts 1a and 2a); From Day 1 to Day 13 (Parts 1b and 2b)
Area under plasma concentration time curve from zero to end of dosing interval (AUCτ)
Time frame: From Day 1 to Day 13 (Parts 1b and 2b)
Area under plasma concentration time curve from zero to end of dosing interval, by dose (AUCτ/D)
Time frame: From Day 1 to Day 13 (Parts 1b to 2b)
Cough Severity self-assessment as measured by Visual Analogue Scale (VAS)
Time frame: From Day 1 to Day 8 (Parts 1b and 2b)
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 17 Nov 2025.
- D8210C00002\_CSR Synopsis\_RedactedLink provided by the sponsor.
- Astrazenecaclinicaltrials.com-study resultsLink provided by the sponsor.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD4604 in people with Healthy Participants, run by AstraZeneca at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. 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 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
Number of participants with adverse event (AEs) (time frame: From Day -28 to 5 weeks (Parts 1a and 2a); Day -28 to 6 weeks (Parts 1b and 2b)). 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 17 Nov 2025.