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

Safety and Tolerability Clinical Trial

Official title:
Samba-AC: A Randomized, Open-Label, Cross-Over Study to Investigate the PK and PD Profiles of Dance 501 (Human Insulin Inhalation Solution and Inhaler) in Healthy Subjects and Non-Diabetic Subjects With Mild to Moderate Asthma or COPD

Clinical Trial 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).

Clinical Trial Description

The PK and PD profile of Dance 501 (Human Insulin Inhalation Solution and Inhaler) will be compared to subcutaneous injection of insulin lispro. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03307512
Study type Interventional
Source Dance Biopharm Inc.
Contact
Status Terminated
Phase Phase 2
Start date February 6, 2018
Completion date August 30, 2019
View Details
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