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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Chronic Obstructive Pulmonary Disease (COPD).

Treatments: Drug: Placebo; Drug: AZD4721; Drug: AZD5069

Study type: Interventional

Funder types: Industry

Identifiers

NCT01962935

D5200C00002

Details and patient eligibility

About

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

Full 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

Enrollment: 84 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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84 participants in 3 patient groups, including a placebo group

Part A AZD4721

Experimental group

Description:

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

Treatment:

Drug: AZD4721

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

AZD5069, then AZD4721

Active Comparator group

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.

Treatment:

Drug: AZD5069

Drug: AZD4721