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Study to investigate the safety profile of AZD4721 after single doses at different dose levels
A study to investigate safety and tolerability of single ascending doses of AZD4721 given to healthy volunteers. Including a bioequivalence part to compare a solution of AZD4721 with a suspension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A Active | Experimental | AZD4721 Solution |
|
| Part A Placebo | Placebo Comparator | Placebo for AZD4721 |
|
| Part B solution | Experimental | AZD4721 Solution |
|
| Part B Suspension | Active Comparator | AZD4721 Suspension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD4721 Solution | Drug | 1-9 mg/mL liquid solution |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Description of the safety profile in terms of Adverse events; blood pressure, heart rate and body temperature; electrocardiograms; clinical chemistry; haematology assessments, including serial blood neutrophil count | From Screening to follow up ( maximum 7 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Description of the pharmacokinetic(PK) profile for in terms of: observed maximum plasma concentration (Cmax), time to reach maximum plasma concentration (tmax), terminal rate constant (λz), terminal half-life (t½ z). | Sample taken predose, 1, 3, 5, 7, 9, 13, 18, 24, 36, 48, 72, 96, 144, 216 hours postdose | |
| Description of the pharmacokinetic(PK) profile for in terms of: area under the plasma concentration-time curve from time zero to 24 hours after dosing (AUC(0-24)), from time zero to the time of last quantifiable concentration (AUC(0 last)) |
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Inclusion Criteria:
Exclusion Criteria:
2.Clinically significant lower respiratory tract infection not resolved within 4 weeks prior to Visit 1, as determined by the Investigator
4. Other latent or chronic infections (eg, recurrent sinusitis, genital or ocular herpes, urinary tract infection) or at risk of infection (surgery, trauma, or significant infection) in previous 90 days, or history of skin abscesses within the previous
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| Name | Affiliation | Role |
|---|---|---|
| James Ritter, MD | Quintiles London UK | Principal Investigator |
| Bengt Larsson, MD | Astrazeneca Molndal, Sweden | Study Director |
| Stuart Oliver, MD | Astrazeneca UK | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | London | United Kingdom |
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| Label | URL |
|---|---|
| CSR Synopsis | View source |
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| AZD4721 Placebo |
| Drug |
Liquid solution |
|
| AZD4721 Suspension | Drug | 9 mg/g liquid suspension |
|
| Sample taken predose, 1, 3, 5, 7, 9, 13, 18, 24, 36, 48, 72, 96, 144, 216 hours postdose |
| Description of the pharmacokinetic(PK) profile for in terms of from time zero extrapolated to infinity (AUC), apparent clearance for parent drug estimated as dose divided by AUC (CL/F; AZD4721 only) | Sample taken predose, 1, 3, 5, 7, 9, 13, 18, 24, 36, 48, 72, 96, 144, 216 hours postdose |
| Description of the pharmacokinetic(PK) profile in terms of apparent volume of distribution during terminal phase (Vz/F; AZD4721 only), mean residence time (MRT, AZD4721 only), lag-time (T-lag, AZD4721 only), dose-normalized AUC (AUC/D) and Cmax (Cmax/D) | Sample taken predose, 1, 3, 5, 7, 9, 13, 18, 24, 36, 48, 72, 96, 144, 216 hours postdose |
| Description of the pharmacokinetic(PK) profile for in terms of effective half-life (t½(eff)), time of last quantifiable concentration (tlast), predicted accumulation ratio (Rac,pred) | Sample taken predose, 1, 3, 5, 7, 9, 13, 18, 24, 36, 48, 72, 96, 144, 216 hours postdose |
| Description of the pharmacokinetic(PK) profile for in terms of the time interval and number of data points included in the log-linear regression to determine terminal half-life (z,Interval and z,N) | Sample taken predose, 1, 3, 5, 7, 9, 13, 18, 24, 36, 48, 72, 96, 144, 216 hours postdose |
| Description of the pharmacokinetic(PK) profile for in terms of the regression coefficient for calculation of the terminal rate constant (Rsq), and the percentage of area under the curve to infinity obtained by extrapolation (%AUCex). | Sample taken predose, 1, 3, 5, 7, 9, 13, 18, 24, 36, 48, 72, 96, 144, 216 hours postdose |
| Description of the pharmacokinetic(PK) profile for in terms of the metabolic ratios (ratio of metabolite to parent) for AUC and Cmax (MRAUC and MRCmax) | Sample taken predose, 1, 3, 5, 7, 9, 13, 18, 24, 36, 48, 72, 96, 144, 216 hours postdose |