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

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

Status

Withdrawn

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01009424

Enrollment

Registered

2009-11-06

Start date

2009-10-31

Completion date

2009-12-31

Last updated

2016-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Brief summary

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.

Interventions

DRUGR7103

escalating inhaled dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

40 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026