Status:
TERMINATED
PK and PD Profile of Dance 501 in Healthy, Non-diabetic Subjects With Mild to Moderate Asthma or COPD
Lead Sponsor:
Dance Biopharm Inc.
Collaborating Sponsors:
WCCT Global
Conditions:
Safety and Tolerability
Eligibility:
All Genders
30-70 years
Phase:
PHASE2
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 ...
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.
Eligibility Criteria
Inclusion
- non-diabetic subjects with asthma, or COPD. Non-smokers or smokers quit at least 6 months prior to enrollment. BMI \<= 35 kg/m2. Fasting blood glucose \<= 125 mg/dL.
Exclusion
- pulmonary disorder other than asthma or COPD. Upper respiratory within previous 4 weeks. Significant exacerbation of asthma or COPD symptoms. Hospitalization for asthma or COPD within previous 3 months. Clinically significant medical condition. Current medications interfering with glucose metabolism.
Key Trial Info
Start Date :
February 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03307512
Start Date
February 6 2018
End Date
August 30 2019
Last Update
September 13 2019
Active Locations (1)
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1
WCCT
Cypress, California, United States, 90630