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

Sponsor

Dance Biopharm Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT03307512

Collaborator

WCCT Global (Industry)

Enrollment

Location

Arms

18.7

Actual Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Safety and Tolerability	Drug: inhaled human insulin Drug: Insulin Lispro (Humalog U-100)	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Randomized, open-label, cross-over designRandomized, open-label, cross-over design

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Feb 6, 2018

Actual Primary Completion Date :

Jul 30, 2019

Actual Study Completion Date :

Aug 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dance 501 Dance 501(Human Insulin Inhalation Solution and Inhaler) will be administered by inhalation	Drug: inhaled human insulin Dance 501 (Human Insulin Inhalation Solution and Inhaler) will be administered by inhalation Other Names: Dance 501
Active Comparator: Insulin Lispro Insulin Lispro (Humalog®) will be administered by subcutaneous injection	Drug: Insulin Lispro (Humalog U-100) Insulin Lispro (Humalog U-100) will be administered by subcutaneous injection Other Names: Lispro

Arm

Intervention/Treatment

Experimental: Dance 501

Dance 501(Human Insulin Inhalation Solution and Inhaler) will be administered by inhalation

Drug: inhaled human insulin

Dance 501 (Human Insulin Inhalation Solution and Inhaler) will be administered by inhalation

Other Names:

Dance 501

Active Comparator: Insulin Lispro

Insulin Lispro (Humalog®) will be administered by subcutaneous injection

Drug: Insulin Lispro (Humalog U-100)

Insulin Lispro (Humalog U-100) will be administered by subcutaneous injection

Other Names:

Lispro

Outcome Measures

Primary Outcome Measures

Area under the insulin curve (AUC) [10 hours]
Area under the insulin curve (AUC)
Area under the glucose infusion rate curve (GIR) [10 hours]
Area under the glucose infusion rate curve (GIR)

Secondary Outcome Measures

Area under the insulin curve following inhalation of salbutamol [10 hours]
Area under the insulin curve following inhalation of salbutamol in subjects with asthma

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.