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Study to Investigate Safety, Tolerability and Effect of Multiple Dosing With AZD 4721 and/or With AZD 5069

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD).

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
AZD4721
Placebo
AZD5069
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Obstructive Pulmonary Disease (COPD). focused on measuring Healthy volunteer, Multiple ascending dose

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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. ("Healthy" is as determined by medical history and physical examination, clinical laboratory parameters, and ECG and performed before first dose administration.).
  • 3.Healthy volunteers should have a body mass index (BMI) between 18 and 30 kg/m2 (inclusive) and weigh at least 50 kg and no more than 100 kg (inclusive).

Exclusion Criteria:

  1. Pyrexial with a body temperature higher than 37.7°C at Day -1 (Visit 2), or as judged by the investigator.
  2. Screening blood neutrophil counts (taken in the morning) not within the laboratory reference range (Visit 1).
  3. 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 the previous 90 days, or history of skin abscesses within the previous 90 days.
  4. Clinically significant lower respiratory tract infection not resolved within 4 weeks prior to screening (Visit 1), as determined by the investigator.

Sites / Locations

  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Part A AZD4721

Placebo

AZD5069, then AZD4721

Arm Description

Part A of the study, multiple ascending doses of AZD4721 will be administrated once daily for 10 days

Part A of the study, multiple ascending doses of matching Placebo will be administrated once a daily for 14 days

Part 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.

Outcomes

Primary Outcome Measures

Description of the safety profile in terms of Adverse events; blood pressure, heart rate and body temperature; electrocardiograms; clinical chemistry; haematology assessments
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],
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]
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],
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]).
Part A AZD4721
Description of neutrophils in terms of • absolute blood neutrophil count ratio [ANC ratio], time of ANCmin,ss [ANCtmin,ss],
Part B AZD5069
Description of neutrophils in terms of • time of ANCmin,Day 1 [ANCtmin,Day 1],
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]
Part B AZD5069
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]).
Part B AZD5069
Description of neutrophils in terms of • absolute blood neutrophil count ratio [ANC ratio], time of ANCmin,ss [ANCtmin,ss]
Part B AZD4721
Description of neutrophils in terms of time of ANCmin,Day 1 [ANCtmin,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]
Part B 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]).
Part B AZD4721

Secondary Outcome Measures

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)
Following single dose administration of AZD4721 Part A
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)
Following single dose administration of AZD4721 Part A
Description of the PK profile of AZD 4721 in terms of ratio of metabolite Cmax to parent Cmax (MRCmax)
Following single dose administration of AZD4721 Part A
Description of the PK profile of AZD 4721 in terms of Maximum plasma concentration (Css,max), maximum plasma concentration divided by dose (Css,max/D) time to Css,max (tss,max)
Following multiple dose administration of AZD4721Part A
Description of the PK profile of AZD 4721 in terms of minimum plasma concentration (Css,min)), time to Css,min (tss,min) average concentration over the investigational product interval (Css,av)
Following multiple dose administration of AZD4721 Part A
Description of the PK profile of AZD 4721 in terms of peak to trough concentration ratio (Css,max/Css,min)), terminal rate constant (z), terminal half-life (t1/2λz)
Following multiple dose administration of AZD4721 Part A
Description of the PK profile of AZD 4721 in terms of area under the plasma concentration-time curve during the dosing interval at steady state (AUCss,tau), AUCss,tau divided by dose (AUCss,tau/D)
Following multiple dose administration of AZD4721Part A
Description of the PK profile of AZD 4721 in terms of apparent clearance (CL/F), ), volume of distribution (Vz/F)
Following multiple dose administration of AZD4721 Part A
Description of the PK profile of AZD 4721 and metabolite in terms of ratio of metabolite AUCss,tau to parent AUCss,tau (MRAUCss,tau), ratio of metabolite Css,max to parent Css,max (MRCss,max)
Following multiple dose administration of AZD4721 Part A
Description of the PK profile of AZD 4721 and metabolite in terms of accumulation ratio for AUCtau (RAUCtau), and accumulation ratio for Cmax (RCmax).
Following multiple dose administration of AZD4721 Part A
Description of the PK profile of AZD 4721 in terms of Cumulative amount of AZD4721 and AZ13622093 excreted over the investigational product administration interval (Ae (0-tau))
Following multiple dose administration of AZD4721 Part A
Description of the PK profile of AZD 4721 in terms of fraction of dose excreted into the urine over the dosing interval for AZD4721 (fe (0 tau)), and renal clearance (CLR).
Following multiple dose administration of AZD4721 Part A
Description of PK Profile of AZD5069 in terms of observed global maximum concentration (Css,max), time to global Css,max (tss,max), observed global minimum concentration (Css,min)
Following multiple dosing of AZD5069 Part B
Description of PK Profile of AZD5069 in terms of time to global Css,min (tss,min), average concentration over 24 hours (Css,av), peak to trough concentration ratio (Css,max/Css,min)
Following multiple dosing of AZD5069 Part B
Description of PK Profile of AZD5069 in terms of AUC during the 12 hour interval after the morning dose(AUCtau,morning), AUC during the 12 hour dosing interval after the evening dose (AUCtau,evening)
Following multiple dosing of AZD5069 Part B
Description of PK Profile of AZD5069 in terms of and area under the plasma concentration time curve 0 to 24 hours post morning dose (AUC(0 24h)).
Following multiple dosing of AZD5069 Part B
Description of PK Profile of AZD4721 in terms of maximum plasma concentration (Css,max), time to Css,max (tss,max), minimum plasma concentration (Css,min), time to Css,min (tss,min), average concentration over the dosing interval (Css,av)
Following multiple dosing of AZD4721 Part B
Description of PK Profile of AZD4721 in terms of peak to trough concentration ratio (Css,max/Css,min), area under the plasma concentration time curve during the dosing interval (AUCss,tau), and apparent clearance (CL/F).
Following multiple dosing of AZD4721 Part B

Full Information

First Posted
October 11, 2013
Last Updated
June 24, 2015
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01962935
Brief Title
Study to Investigate Safety, Tolerability and Effect of Multiple Dosing With AZD 4721 and/or With AZD 5069
Official Title
A Phase I Study in Healthy Volunteers to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD4721 After Once Daily Administration of Multiple Ascending Doses for 10 Days, and an Open-label Comparison With the Pharmacodynamics of AZD5069 Given Twice Daily for 3 Days
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Study to investigate safety, tolerability and effect of multiple dosing with AZD 4721 and/or with AZD 5069
Detailed Description
The purpose of the study is to investigate the safety and tolerability, pharmacokinetics and pharmacodynamics of AZD 4721 in healthy volunteers after once daily administration of multiple ascending doses for 10 days, and an open-label comparison with the pharmacodynamics of AZD5069 given twice daily for 3 days

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD).
Keywords
Healthy volunteer, Multiple ascending dose

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part A AZD4721
Arm Type
Experimental
Arm Description
Part A of the study, multiple ascending doses of AZD4721 will be administrated once daily for 10 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Part A of the study, multiple ascending doses of matching Placebo will be administrated once a daily for 14 days
Arm Title
AZD5069, then AZD4721
Arm Type
Active Comparator
Arm Description
Part 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.
Intervention Type
Drug
Intervention Name(s)
AZD4721
Intervention Description
Part A - multiple ascending dose, daily; Part B - one dose decided after part A, daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Part A - multiple ascending dose daily
Intervention Type
Drug
Intervention Name(s)
AZD5069
Intervention Description
Part B - one dose decided after part A, twice a day
Primary Outcome Measure Information:
Title
Description of the safety profile in terms of Adverse events; blood pressure, heart rate and body temperature; electrocardiograms; clinical chemistry; haematology assessments
Description
Same for both part A and B
Time Frame
From Admission day -1 up to Follow up ( Max 12 weeks)
Title
Description of neutrophils in terms of absolute blood neutrophil count ratio [ANC ratio], time of ANCmin,ss [ANCtmin,ss],
Description
Part A AZD4721
Time Frame
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).
Title
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]
Description
Part A AZD4721
Time Frame
Samples taken for Part A Day 1 at predose, 1h,2h,6h12h and 24h postdose.
Title
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],
Description
Part A AZD4721
Time Frame
Samples taken for Part A day10 predose and at 1h,2h,3h,6h,9h,12h,15h,18h,21h,24h post dose
Title
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]).
Description
Part A AZD4721
Time Frame
Samples taken for Part A day 10 predose and at 1h,2h,3h,6h,9h,12h,15h,18h,21h,24h post dose
Title
Description of neutrophils in terms of • absolute blood neutrophil count ratio [ANC ratio], time of ANCmin,ss [ANCtmin,ss],
Description
Part B AZD5069
Time Frame
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
Title
Description of neutrophils in terms of • time of ANCmin,Day 1 [ANCtmin,Day 1],
Description
Part B AZD5069
Time Frame
Part B day 1 predose, 12h and 24h postdose
Title
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]
Description
Part B AZD5069
Time Frame
Samples taken Part B day 3 predose,3h,6h,9h,12h,15h,18h,21h and 24h post dose
Title
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]).
Description
Part B AZD5069
Time Frame
Samples taken Part B day 3 predose,3h,6h,9h,12h,15h,18h,21h and 24h post dose
Title
Description of neutrophils in terms of • absolute blood neutrophil count ratio [ANC ratio], time of ANCmin,ss [ANCtmin,ss]
Description
Part B AZD4721
Time Frame
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
Title
Description of neutrophils in terms of time of ANCmin,Day 1 [ANCtmin,Day 1],
Description
Part B AZD4721
Time Frame
Samples taken for part B predose day 1
Title
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]
Description
Part B AZD4721
Time Frame
Samples taken part B pre dose day 10 and at 1h,2h,3h,6h,9h,12h,15h,18h,21h,24h post dose
Title
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]).
Description
Part B AZD4721
Time Frame
Samples taken part B pre dose day 10 and at 1h,2h,3h,6h,9h,12h,15h,18h,21h,24h post dose
Secondary Outcome Measure Information:
Title
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)
Description
Following single dose administration of AZD4721 Part A
Time Frame
Sample taken Day 1 post dose at 0:20, 0:40,1h, 2h,3h,6h,9h,12h,15h,18h,21h and 24h.
Title
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)
Description
Following single dose administration of AZD4721 Part A
Time Frame
Sample taken Day 1 post dose at 0:20, 0:40,1h, 2h,3h,6h,9h,12h,15h,18h,21h and 24h.
Title
Description of the PK profile of AZD 4721 in terms of ratio of metabolite Cmax to parent Cmax (MRCmax)
Description
Following single dose administration of AZD4721 Part A
Time Frame
Sample taken Day 1 post dose at 0:20, 0:40,1h, 2h,3h,6h,9h,12h,15h,18h,21h and 24h.
Title
Description of the PK profile of AZD 4721 in terms of Maximum plasma concentration (Css,max), maximum plasma concentration divided by dose (Css,max/D) time to Css,max (tss,max)
Description
Following multiple dose administration of AZD4721Part A
Time Frame
Sample taken Day 1 post dose at 0:20, 0:40,1h, 2h,3h,6h,9h,12h,15h,18h,21h and 24h. Predose day 3,4,5,6,7,8,9,10 and at 0:20,0:40,1h,2h,3h,6h,9h,12h,15h,18h,21h,24h,48h,72h and 96h post last dose
Title
Description of the PK profile of AZD 4721 in terms of minimum plasma concentration (Css,min)), time to Css,min (tss,min) average concentration over the investigational product interval (Css,av)
Description
Following multiple dose administration of AZD4721 Part A
Time Frame
Sample taken Day 1 post dose at 0:20, 0:40,1h, 2h,3h,6h,9h,12h,15h,18h,21h and 24h. Predose day 3,4,5,6,7,8,9,10 and at 0:20,0:40,1h,2h,3h,6h,9h,12h,15h,18h,21h,24h,48h,72h and 96h post last dose
Title
Description of the PK profile of AZD 4721 in terms of peak to trough concentration ratio (Css,max/Css,min)), terminal rate constant (z), terminal half-life (t1/2λz)
Description
Following multiple dose administration of AZD4721 Part A
Time Frame
Sample taken Day 1 post dose at 0:20, 0:40,1h, 2h,3h,6h,9h,12h,15h,18h,21h and 24h. Predose day 3,4,5,6,7,8,9,10 and at 0:20,0:40,1h,2h,3h,6h,9h,12h,15h,18h,21h,24h,48h,72h and 96h post last dose
Title
Description of the PK profile of AZD 4721 in terms of area under the plasma concentration-time curve during the dosing interval at steady state (AUCss,tau), AUCss,tau divided by dose (AUCss,tau/D)
Description
Following multiple dose administration of AZD4721Part A
Time Frame
Sample taken Day 1 post dose at 0:20, 0:40,1h, 2h,3h,6h,9h,12h,15h,18h,21h and 24h. Predose day 3,4,5,6,7,8,9,10 and at 0:20,0:40,1h,2h,3h,6h,9h,12h,15h,18h,21h,24h,48h,72h and 96h post last dose
Title
Description of the PK profile of AZD 4721 in terms of apparent clearance (CL/F), ), volume of distribution (Vz/F)
Description
Following multiple dose administration of AZD4721 Part A
Time Frame
Sample taken Day 1 post dose at 0:20, 0:40,1h, 2h,3h,6h,9h,12h,15h,18h,21h and 24h. Predose day 3,4,5,6,7,8,9,10 and at 0:20,0:40,1h,2h,3h,6h,9h,12h,15h,18h,21h,24h,48h,72h and 96h post last dose
Title
Description of the PK profile of AZD 4721 and metabolite in terms of ratio of metabolite AUCss,tau to parent AUCss,tau (MRAUCss,tau), ratio of metabolite Css,max to parent Css,max (MRCss,max)
Description
Following multiple dose administration of AZD4721 Part A
Time Frame
Sample taken Day 1 post dose at 0:20, 0:40,1h, 2h,3h,6h,9h,12h,15h,18h,21h and 24h. Predose day 3,4,5,6,7,8,9,10 and at 0:20,0:40,1h,2h,3h,6h,9h,12h,15h,18h,21h,24h,48h,72h and 96h post last dose
Title
Description of the PK profile of AZD 4721 and metabolite in terms of accumulation ratio for AUCtau (RAUCtau), and accumulation ratio for Cmax (RCmax).
Description
Following multiple dose administration of AZD4721 Part A
Time Frame
Sample taken Day 1 post dose at 0:20, 0:40,1h, 2h,3h,6h,9h,12h,15h,18h,21h and 24h. Predose day 3,4,5,6,7,8,9,10 and at 0:20,0:40,1h,2h,3h,6h,9h,12h,15h,18h,21h,24h,48h,72h and 96h post last dose
Title
Description of the PK profile of AZD 4721 in terms of Cumulative amount of AZD4721 and AZ13622093 excreted over the investigational product administration interval (Ae (0-tau))
Description
Following multiple dose administration of AZD4721 Part A
Time Frame
Urine collection 24h from 0h-24 day 10
Title
Description of the PK profile of AZD 4721 in terms of fraction of dose excreted into the urine over the dosing interval for AZD4721 (fe (0 tau)), and renal clearance (CLR).
Description
Following multiple dose administration of AZD4721 Part A
Time Frame
Urine collection 24h from 0h-24 day 10
Title
Description of PK Profile of AZD5069 in terms of observed global maximum concentration (Css,max), time to global Css,max (tss,max), observed global minimum concentration (Css,min)
Description
Following multiple dosing of AZD5069 Part B
Time Frame
Sample taken day 1 12h, day 2 0h and 12h, day 3 0h,3h,6h,9h,12h,15h,18h,21h and 24h post dose
Title
Description of PK Profile of AZD5069 in terms of time to global Css,min (tss,min), average concentration over 24 hours (Css,av), peak to trough concentration ratio (Css,max/Css,min)
Description
Following multiple dosing of AZD5069 Part B
Time Frame
Sample taken day 1 12h, day 2 0h and 12h, day 3 0h,3h,6h,9h,12h,15h,18h,21h and 24h post dose
Title
Description of PK Profile of AZD5069 in terms of AUC during the 12 hour interval after the morning dose(AUCtau,morning), AUC during the 12 hour dosing interval after the evening dose (AUCtau,evening)
Description
Following multiple dosing of AZD5069 Part B
Time Frame
Sample taken day 1 12h, day 2 0h and 12h, day 3 0h,3h,6h,9h,12h,15h,18h,21h and 24h post dose
Title
Description of PK Profile of AZD5069 in terms of and area under the plasma concentration time curve 0 to 24 hours post morning dose (AUC(0 24h)).
Description
Following multiple dosing of AZD5069 Part B
Time Frame
Sample taken day 1 12h, day 2 0h and 12h, day 3 0h,3h,6h,9h,12h,15h,18h,21h and 24h post dose
Title
Description of PK Profile of AZD4721 in terms of maximum plasma concentration (Css,max), time to Css,max (tss,max), minimum plasma concentration (Css,min), time to Css,min (tss,min), average concentration over the dosing interval (Css,av)
Description
Following multiple dosing of AZD4721 Part B
Time Frame
Sample taken predose Day 2,4,6,8,10 and at 0:20h,0:40h,1h,2h,3h,6h,9h,12h,15h,18h,21h and 24h post dose
Title
Description of PK Profile of AZD4721 in terms of peak to trough concentration ratio (Css,max/Css,min), area under the plasma concentration time curve during the dosing interval (AUCss,tau), and apparent clearance (CL/F).
Description
Following multiple dosing of AZD4721 Part B
Time Frame
Sample taken predose Day 2,4,6,8,10 and at 0:20h,0:40h,1h,2h,3h,6h,9h,12h,15h,18h,21h and 24h post dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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. ("Healthy" is as determined by medical history and physical examination, clinical laboratory parameters, and ECG and performed before first dose administration.). 3.Healthy volunteers should have a body mass index (BMI) between 18 and 30 kg/m2 (inclusive) and weigh at least 50 kg and no more than 100 kg (inclusive). Exclusion Criteria: Pyrexial with a body temperature higher than 37.7°C at Day -1 (Visit 2), or as judged by the investigator. Screening blood neutrophil counts (taken in the morning) not within the laboratory reference range (Visit 1). 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 the previous 90 days, or history of skin abscesses within the previous 90 days. Clinically significant lower respiratory tract infection not resolved within 4 weeks prior to screening (Visit 1), as determined by the investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonard Siew, MD
Organizational Affiliation
Quintiles London, UK
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bengt Larsson, MD
Organizational Affiliation
Astrazeneca Mölndal, Sweden
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
London
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1878&filename=D5200C00002_Study_Synopsis.pdf
Description
CSR Synopsis

Learn more about this trial

Study to Investigate Safety, Tolerability and Effect of Multiple Dosing With AZD 4721 and/or With AZD 5069

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