To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Doses of Inhaled AZD7594

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Pharmacodynamics of AZD7594; Pharmacokinetics; Safety

Treatments: Drug: AZD7594; Drug: Placebo to match

Study type: Interventional

Funder types: Industry

Identifiers

NCT01636024

D3740C00001

Details and patient eligibility

About

The purpose of this study is to evaluate the safety profile and look at levels of AZD7594 and biomarkers in blood when the drug is administered inhaled to healthy subjects

Full description

A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single and Multiple Ascending Inhaled Doses of AZD7594 in Healthy Male Volunteers

Enrollment: 73 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male volunteers aged 18-45 years inclusive with suitable veins for cannulation or repeated vein puncture
• Have a body mass index (BMI) between 18 and 30 kg/m2 and weight between 50 and 100 kg (inclusive)
• Be able to inhale from the Spira nebuliser used in the study
• Be willing to use a condom with spermicide to prevent pregnancy and drug exposure of a female partner

Exclusion criteria

• History of any clinically significant disease or disorder
• Current smokers
• Any clinically relevant abnormal findings

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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73 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Subjects will participate in 1 of up to 9 groups in Part A (single ascending dose part) or 1 of 4 groups in Part B (multiple ascending dose part). Ratio of subjects receiving AZD7594 versus placebo is 6:2 in part A and 6:3 in Part B.

Treatment:

Drug: AZD7594

2

Placebo Comparator group

Description:

Subjects will participate in 1 of up to 9 groups in Part A or 1 of 4 groups in Part B. Ratio of subjects receiving AZD7594 versus placebo is 6:2 in part A and 6:3 in Part B.

Treatment:

Drug: Placebo to match