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

Study Overview
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Brief Summary
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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).

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

Official Title
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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

Conditions
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Safety and Tolerability

Intervention / Treatment
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* Drug: inhaled human insulin
* Drug: Insulin Lispro (Humalog U-100)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized, open-label, cross-over design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dance 501<br>Dance 501(Human Insulin Inhalation Solution and Inhaler) will be administered by inhalation | Drug: inhaled human insulin<br>* Dance 501 (Human Insulin Inhalation Solution and Inhaler) will be administered by inhalation<br>* Other names: Dance 501;|
| Active Comparator: Insulin Lispro<br>Insulin Lispro (Humalog®) will be administered by subcutaneous injection | Drug: Insulin Lispro (Humalog U-100)<br>* Insulin Lispro (Humalog U-100) will be administered by subcutaneous injection<br>* Other names: Lispro;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the insulin curve (AUC) | Area under the insulin curve (AUC) | 10 hours | 
| Area under the glucose infusion rate curve (GIR) | Area under the glucose infusion rate curve (GIR) | 10 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the insulin curve following inhalation of salbutamol | Area under the insulin curve following inhalation of salbutamol in subjects with asthma | 10 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inhaled insulin, asthma, COPD