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AZD4721

Phase 1

Chronic Obstructive Pulmonary Disease (COPD). | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Jun 25, 2015

Success Probability

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Trial Design

RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment84

FDA Designations

No designations recorded

Clinical trial landscape

AZD4721 · 2 trials · 2 indications

Phase 1 2
NCT01962935Study to Investigate Safety, Tolerability and Effect of Multiple Dosing With AZD 4721 and/or With AZD 5069Chronic Obstructive Pulmonary Disease (COPD).
COMPLETED84 Analytics
NCT01889160Study to Investigate the Safety Profile of AZD4721 After Single Doses at Different Dose LevelsSafety,Plasma AUC and Cmax, Plasma AUC 0-t, t1/2λz, and Tmax
COMPLETED44 Analytics
PHASE1COMPLETED
Study to Investigate Safety, Tolerability and Effect of Multiple Dosing With AZD 4721 and/or With AZD 5069
Chronic Obstructive Pulmonary Disease (COPD).
NCT0196293584
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PHASE1COMPLETED
Study to Investigate the Safety Profile of AZD4721 After Single Doses at Different Dose Levels
Safety,Plasma AUC and Cmax, Plasma AUC 0-t, t1/2λz, and Tmax
NCT0188916044
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Study Endpoints

Primary Endpoints

Description of the safety profile in terms of Adverse events; blood pressure, heart rate and body temperature; electrocardiograms; clinical chemistry; haematology assessments
From Admission day -1 up to Follow up ( Max 12 weeks)

Same for both part A and B

Description of neutrophils in terms of absolute blood neutrophil count ratio [ANC ratio], time of ANCmin,ss [ANCtmin,ss],
Samples taken for part A day -1, Day 1 at predose,1h,2h,6h and 12h postdose, predose day 2,3,4,5,6,7,8,9,10 predose and at 1h,2h,3h,6h,9h,12h,15h,18h,21h,24h,36h,48h post last dose ( given day 10).

Part A AZD4721

Description of neutrophils in terms of minimum ANC during first 24 hours on Day 1 [Part A only, ANCmin,Day 1], time of ANCmin,Day 1 [ANCtmin,Day 1], minimum ANC ratio during first 24 hours on Day 1 [Part A only, ANCmin ratio,Day 1]
Samples taken for Part A Day 1 at predose, 1h,2h,6h12h and 24h postdose.

Part A AZD4721

Descriptions of neutrophils in terms of minimum ANC during the 24 hours following the last morning dose [ANCmin,ss], mean of ANC values during the 24 hours following the last morning dose [ANCmean,ss],
Samples taken for Part A day10 predose and at 1h,2h,3h,6h,9h,12h,15h,18h,21h,24h post dose

Part A AZD4721

Description of neutrophils in terms of minimum ANC ratio during the 24 hours following the last morning dose [ANCmin ratio,ss], and mean of ANC ratio values during the 24 hours following the last morning dose [ANCmean ratio,ss]).
Samples taken for Part A day 10 predose and at 1h,2h,3h,6h,9h,12h,15h,18h,21h,24h post dose

Part A AZD4721

Description of neutrophils in terms of • absolute blood neutrophil count ratio [ANC ratio], time of ANCmin,ss [ANCtmin,ss],
Part B visit 1 day -1, day 1 predose, 12h, day 2 predose, day 3 predose,3h,6h,9h,12h,15h,18h,21h and 24h post dose

Part B AZD5069

Description of neutrophils in terms of • time of ANCmin,Day 1 [ANCtmin,Day 1],
Part B day 1 predose, 12h and 24h postdose

Part B AZD5069

Description of neutrophile in terms of minimum ANC during the 24 hours following the last morning dose [ANCmin,ss], mean of ANC values during the 24 hours following the last morning dose [ANCmean,ss]
Samples taken Part B day 3 predose,3h,6h,9h,12h,15h,18h,21h and 24h post dose

Part B AZD5069

Description of neutrophils in terms of • absolute blood neutrophil count ratio [ANC ratio], time of ANCmin,ss [ANCtmin,ss]
Samples taken for part B day -1, predose day 1,2,4,6,8,10 and at 1h,2h,3h,6h,9h,12h,15h,18h,21h,24h post dose

Part B AZD4721

Description of neutrophils in terms of time of ANCmin,Day 1 [ANCtmin,Day 1],
Samples taken for part B predose day 1

Part B AZD4721

Description of neutrophils in terms of minimum ANC during the 24 hours following the last morning dose [ANCmin,ss], mean of ANC values during the 24 hours following the last morning dose [ANCmean,ss]
Samples taken part B pre dose day 10 and at 1h,2h,3h,6h,9h,12h,15h,18h,21h,24h post dose

Part B AZD4721

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)

Secondary Endpoints

Description of the pharmacokinetic(PK) profile of AZD 4721 in terms of Maximum plasma concentration (Cmax), maximum plasma concentration divided by dose (Cmax/D), time to Cmax (tmax)
Sample taken Day 1 post dose at 0:20, 0:40,1h, 2h,3h,6h,9h,12h,15h,18h,21h and 24h.
Description of the PK profile of AZD 4721 in terms of area under the plasma concentration-time curve during the dosing interval (AUCtau),), lag-time (tlag), ratio of metabolite AUCtau to parent AUCtau (MRAUC)
Sample taken Day 1 post dose at 0:20, 0:40,1h, 2h,3h,6h,9h,12h,15h,18h,21h and 24h.
Description of the PK profile of AZD 4721 in terms of ratio of metabolite Cmax to parent Cmax (MRCmax)
Sample taken Day 1 post dose at 0:20, 0:40,1h, 2h,3h,6h,9h,12h,15h,18h,21h and 24h.
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Part A AZD4721EXPERIMENTALPart A of the study, multiple ascending doses of AZD4721 will be administrated once daily for 10 days
PlaceboPLACEBO_COMPARATORPart A of the study, multiple ascending doses of matching Placebo will be administrated once a daily for 14 days
AZD5069, then AZD4721ACTIVE_COMPARATORPart B of the study, subject will participate in two treatment periods (one with AZD5069 administrated for 3 days and the second period with AZD4721 administrated for 14 days) separated by a wash-out period of 6-10 days between the two periods.
Part A ActiveEXPERIMENTALAZD4721 Solution
Part A PlaceboPLACEBO_COMPARATORPlacebo for AZD4721
Part B solutionEXPERIMENTALAZD4721 Solution
Part B SuspensionACTIVE_COMPARATORAZD4721 Suspension

Interventions

NameTypeDescription
AZD4721DRUGPart A - multiple ascending dose, daily; Part B - one dose decided after part A, daily
PlaceboDRUGPart A - multiple ascending dose daily
AZD5069DRUGPart B - one dose decided after part A, twice a day
AZD4721 SolutionDRUG1-9 mg/mL liquid solution
AZD4721 PlaceboDRUGLiquid solution
AZD4721 SuspensionDRUG9 mg/g liquid suspension
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Eligibility Criteria

Age Range18 Years to 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * 1.Provision of signed and dated, written informed consent prior to any study specific procedures. * 2.Healthy male and/or female Caucasian (neither Black/African American nor Japanese) volunteers aged 18 to 50 years with suitable veins for cannulation or repeated venipuncture....

Countries:United Kingdom
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Frequently asked questions about AZD4721

What is AZD4721 used for?

AZD4721 is an investigational small molecule being studied for Chronic Obstructive Pulmonary Disease (COPD). It is in Phase 1 clinical development and is not yet approved. The drug is being evaluated for its safety, tolerability, and pharmacokinetic profile, including plasma AUC and Cmax.

Who makes AZD4721?

AZD4721 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker AZN. The drug is currently in Phase 1 clinical trials for respiratory conditions.

What phase is AZD4721 in?

AZD4721 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 1 trials have been completed, both in the United Kingdom.

What clinical trials is AZD4721 in?

AZD4721 has been studied in two completed Phase 1 trials. NCT01889160 investigated the safety profile after single doses, and NCT01962935 investigated safety, tolerability, and effect of multiple dosing with AZD4721 and/or AZD 5069. Both trials were conducted in the United Kingdom.

How does AZD4721 work?

AZD4721 is a small molecule being developed for Chronic Obstructive Pulmonary Disease (COPD). Its specific molecular target has not been disclosed in available information, so its mechanism of action is not fully characterized in public data.