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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-06-30

Brief Summary

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Study to investigate safety, tolerability and effect of multiple dosing with AZD 4721 and/or with AZD 5069

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Detailed Description

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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

Conditions

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Chronic Obstructive Pulmonary Disease (COPD).

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Part A AZD4721

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

Group Type EXPERIMENTAL

AZD4721

Intervention Type DRUG

Part A - multiple ascending dose, daily; Part B - one dose decided after part A, daily

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Part A - multiple ascending dose daily

AZD5069, then AZD4721

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.

Group Type ACTIVE_COMPARATOR

AZD4721

Intervention Type DRUG

Part A - multiple ascending dose, daily; Part B - one dose decided after part A, daily

AZD5069

Intervention Type DRUG

Part B - one dose decided after part A, twice a day

Interventions

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AZD4721

Part A - multiple ascending dose, daily; Part B - one dose decided after part A, daily

Intervention Type DRUG

Placebo

Part A - multiple ascending dose daily

Intervention Type DRUG

AZD5069

Part B - one dose decided after part A, twice a day

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes