Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
A Phase Ib Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of Repeated Administration, Intravenous MN-221 in Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Patients
In MediciNova's clinical development plan for MN-221, it was recognized that treatment of
COPD exacerbations may necessitate more than one single i.v. infusion and that patients in
this population may have more co-morbidities (and concomitant medications) than has been
generally studied so far. Thus, the primary objective of this clinical study is to determine
the repeated administration safety and tolerability of intravenous (i.v.) MN-221 compared to
placebo with repeated administration over several days in moderate to severe COPD patients
who may also have co-morbidities and concomitant medications (CM) common in this population.
Secondary outcomes include pharmacokinetics (PK) and preliminary efficacy (FEV1).
This Phase 1b trial follows naturally upon a Phase 1b COPD trial completed last year
(MN-221-CL-010) and is additionally well-supported by relevant animal safety data and human
clinical trial information.
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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