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



Status:Recruiting
Healthy:No
Age Range:30 - 70
Updated:2/28/2019
Start Date:February 6, 2018
End Date:August 30, 2019
Contact:Debbie D Tranowski
Email:dtranowski@dancebiopharm.com
Phone:(650)269-6287

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Trial Summary
Trial Overview
Inclusion Criteria

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

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).

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

Inclusion Criteria:

- 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 Criteria:

- 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.
We found this trial at
1
site
WCCT
Cypress, California 90630
Phone: 714-252-0700
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Cypress, CA
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