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MN-221

Safety Study to Evaluate MN-221 in Chronic Obstructive Pulmonary Disease (COPD) Patients

Ensayo de MEDICINOVA INC en EPOC.

Más ensayos de: EPOC.

Fase

Fase 1

Estado

Completado

Participantes

19

previstos

Centros

2

Fin del objetivo primario

may 2012

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en mar 2012.

Qué mide

Number of Participants with Adverse Events as a Measure of Safety and Tolerability (Treatment Days 1- 5) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroIn 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.

Más ensayos de MNOV

Todos los de MNOV, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01551316), actualizada en may 2012.