drugset / Trial / NCT03307512

PK and PD Profile of Dance 501 in Healthy, Non-diabetic Subjects With Mild to Moderate Asthma or COPD

NCT03307512

Phase 2 Terminated 40 enrolled Dance Biopharm Inc. WCCT Global · collab
RandomizedCrossoverOpen-labelTreatment

Summary

This will be a randomized, open-label, active-controlled, single dose crossover study with either three or four treatment periods. Investigational treatment is with Dance 501 Human Insulin Inhalation Solution (Dance 501) and the comparator is Insulin Lispro (Humalog®). Target population will be Non-Diabetic individuals with mild to moderate asthma or chronic obstructive pulmonary disease (COPD) and non-diabetic individuals without underlying lung disease (healthy subjects).

Timeline

Start
2018-02-06
Primary completion
2019-07-30
Completion
2019-08-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Insulin Protein / enzyme biologic Other
Comparator Insulin Lispro Protein / enzyme biologic Subcutaneous

Indications

No indication recorded.