drugset / Trial / NCT03307512
PK and PD Profile of Dance 501 in Healthy, Non-diabetic Subjects With Mild to Moderate Asthma or COPD
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Insulin | Protein / enzyme biologic | — | Other |
| Comparator | Insulin Lispro | Protein / enzyme biologic | — | Subcutaneous |
Indications
No indication recorded.