AZD9164 Single Ascending Dose Study in Healthy Male Subjects

AstraZeneca65 enrolled

Overview

The aims of the study are to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD9164 following single ascending dose administrations to healthy male subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Healthy

Interventions

AZD9164DRUG

Each subject will receive a single-dose starting dose 4µg (lung deposited dose) with up to 8 dose escalations not exceeding AstraZeneca pre-defined exposure limits.

PlaceboDRUG

Each subject will receive a single-dose.

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Provision of signed, written and dated informed consent prior to any study specific procedures * Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg * Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for \>6 months prior to study start Exclusion Criteria: * Any clinically significant disease or disorder * Any clinically significant abnormalities at screening examinations * Use of any prescribed or non-prescribed medication

Locations (1)

Research Site

Lund, Sweden

Outcomes

Primary Outcomes

Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab)

Time frame: up to 48 hours post-dose.

Secondary Outcomes

Pharmacokinetics

Time frame: up to 48 hours post-dose.

Local and extrapulmonary effects

Time frame: up to 48 hours post-dose.

Data from ClinicalTrials.gov

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