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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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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.
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:
Part 1b and Part 2b will comprise of:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1a: AZD4604 (Dose 1) SAD | Experimental | Japanese participants will receive single dose of AZD4604 (Dose 1) via inhalation on Day 1. |
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| Part 1a: AZD4604 (Dose 2) SAD | Experimental | Japanese participants will receive single dose of AZD4604 (Dose 2) via inhalation on Day 1. |
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| Part 1a: AZD4604 (Dose 3) SAD | Experimental | Japanese participants will receive single dose of AZD4604 (Dose 3) via inhalation on Day 1. |
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| Part 1a: Placebo | Placebo Comparator | Japanese participants will receive single dose of matching placebo to AZD4604 on Day 1. |
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| 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. |
|
| Part 1b: Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD4604 | Drug | AZD4604 will be administered as Dry Powder Inhalation (DPI). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From Day -28 to 5 weeks (Parts 1a and 2a); Day -28 to 6 weeks (Parts 1b and 2b) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Harrow | HA1 3UJ | United Kingdom |
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| Label | URL |
|---|---|
| D8210C00002\_CSR Synopsis\_Redacted | View source |
| Astrazenecaclinicaltrials.com-study results | View source |
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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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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.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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Japanese participants will receive matching placebo to AZD4604 BID from day 1 to day 6 and a single dose of placebo on Day 7. |
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| Part 2a: AZD4604 (Dose 1) SAD | Experimental | Chinese participants will receive single dose of AZD4604 (Dose 1) via inhalation on Day 1. |
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| Part 2a: AZD4604 (Dose 3) SAD | Experimental | Chinese participants will receive single dose of AZD4604 (Dose 3) via inhalation on Day 1. |
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| Part 2a: Placebo | Placebo Comparator | Chinese participants will receive single dose of matching placebo to AZD4604 on Day 1. |
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| 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. |
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| 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. |
|
| Placebo | Drug | Placebo will be administered as DPI. |
|
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). |
| 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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). | 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. | From Day 1 to Day 8 (Parts 1b and 2b) |