A Multi-center Study to Investigate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of R7103 Following Repeated Inhalation in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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This study will assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of RO5024118 following repeated inhalation in patients with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD). Patients will be randomized to receive multiple inhaled doses of R7103, as compared with placebo. The target sample size is approximately 30 individuals.

Official Title
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A Multi-center, Placebo-controlled, Double Blind Multiple-ascending Dose Study in a Leapfrog Design to Investigate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of RO5024118 Following Repeated Inhalation in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease

Conditions
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COPD

Intervention / Treatment
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* Drug: R7103


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients 40-70 years of age, inclusive. Body Mass Index 18-32 kg/m2, inclusive. Female patients must be surgically sterile or post menopausal for the past year confirmed by a negative hormone panel. Male patients and their partners of childbearing potential must use two methods of contraception, one of which must be a barrier method for the duration of the study and for 7 days after last dose. Diagnosis of moderate-to-severe COPD (GOLD Stage II-III). Exclusion Criteria: Current smoker or history of smoking in the last three months. Use of continuous daily long term oxygen therapy or requirement for oxygen therapy during exercise. History of cardiac conduction abnormalities or ventricular tachyarrhythmias. Exacerbation of COPD within 8 weeks before first dosing.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>R7103 (dose 1) followed by placebo or placebo followed by R7103 (dose 1) | Drug: R7103<br>* escalating inhaled dose<br>|
| Experimental: 2<br>R7103 (dose 2) followed by placebo or placebo followed by R7103 (dose 2) | Drug: R7103<br>* escalating inhaled dose<br>|
| Experimental: 3<br>R7103 (dose 3) followed by placebo or placebo followed by R7103 (dose 3) | Drug: R7103<br>* escalating inhaled dose<br>|
| Experimental: 4<br>R7103 (dose 4) followed by placebo or placebo followed by R7103 (dose 4) | Drug: R7103<br>* escalating inhaled dose<br>|
| Experimental: 5<br>R7103 (dose 5) followed by placebo or placebo followed by R7103 (dose 5) | Drug: R7103<br>* escalating inhaled dose<br>|
| Experimental: 6<br>R7103 (dose 6) followed by placebo or placebo followed by R7103 (dose 6) | Drug: R7103<br>* escalating inhaled dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the safety and tolerability of multiple inhaled doses of R7103 as compared to placebo, and to define the Maximum Tolerated Dose (MTD) in target population |  | 18 days per arm |