Ignite Creation Date:
2024-05-06 @ 10:37 AM
Last Modification Date:
2024-10-26 @ 12:33 PM
Study NCT ID:
NCT03307512
Status:
TERMINATED
Last Update Posted:
2019-09-13
First Post:
2017-10-02
Brief Title:
PK and PD Profile of Dance 501 in Healthy Non-diabetic Subjects With Mild to Moderate Asthma or COPD
Sponsor:
Dance Biopharm Inc
Organization:
Dance Biopharm Inc
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Termination due to incomplete enrollment planned data analysis not performed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None