Single Centre, Double-blind, Single and Multiple Ascending Inhaled Doses of AZD9819 in Healthy Subjects

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers; Tolerability; Safety

Treatments: Drug: Placebo; Drug: AZD9819

Study type: Interventional

Funder types: Industry

Identifiers

NCT01166698

D3020C00001

Details and patient eligibility

About

The purpose of the study is to assess safety and tolerability of AZD9819 following inhaled administration of single and multiple increasing doses, and to estimate the maximum dose that is tolerated in healthy people.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provision of signed and dated, written informed consent prior to any study specific procedures
• Healthy male and female (non-child bearing potential) subjects aged 18 to 50 years with suitable veins for cannulation or repeated venepuncture.
• Have a body mass index (BMI) between 18 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg

Exclusion criteria

• Any clinically significant disease or disorder
• Any clinically significant abnormalities at screening examination
• Use of any prescribed or non-prescribed medication

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

100 participants in 2 patient groups, including a placebo group

AZD9819

Experimental group

Description:

Inhaled suspension

Treatment:

Drug: AZD9819

Drug: AZD9819

Placebo

Placebo Comparator group

Description:

Inhaled suspension

Treatment:

Drug: Placebo