Multiple Ascending Doses (MAD) of AZD3199 Given Once Daily as Inhaled Formulation Via Turbuhaler to Healthy Men (AZD3199MAD)

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: AZD3199

Study type: Interventional

Funder types: Industry

Identifiers

NCT00713271

D0570C00002

Details and patient eligibility

About

The purpose of this study is to investigate the safety and tolerability of multiple once daily ascending doses of AZD3199 in healthy men

Enrollment: 27 estimated patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• BMI 19-30, weight 60-100 kg
• Non/ex-smokers, Non/ex-nicotine users

Exclusion criteria

• Any clinically significant disease or disorder
• Any clinically relevant abnormal findings at screening examinations
• Use of any prescribed or non-prescribed medication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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27 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

Low dose

Treatment:

Drug: AZD3199

Drug: AZD3199

Drug: AZD3199

2

Experimental group

Description:

intermediate dose

Treatment:

Drug: AZD3199

Drug: AZD3199

Drug: AZD3199

3

Experimental group

Description:

high dose

Treatment:

Drug: AZD3199

Drug: AZD3199

Drug: AZD3199

4

Placebo Comparator group

Treatment:

Drug: Placebo