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

Safety and Tolerability Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03307512
• Other study ID #: Samba-AC
• Status: Terminated
• Phase: Phase 2
• Start date: February 6, 2018
• Est. completion date: August 30, 2019

Study information

• Verified date: September 2019
• Source: Dance Biopharm Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: August 30, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Safety and Tolerability

Intervention

Drug:
• inhaled human insulin
Dance 501 (Human Insulin Inhalation Solution and Inhaler) will be administered by inhalation
• Insulin Lispro (Humalog U-100)
Insulin Lispro (Humalog U-100) will be administered by subcutaneous injection

Locations

Country	Name	City	State
United States	WCCT	Cypress	California

Sponsors (2)

Lead Sponsor	Collaborator
Dance Biopharm Inc.	WCCT Global

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the insulin curve (AUC)	Area under the insulin curve (AUC)	10 hours
Primary	Area under the glucose infusion rate curve (GIR)	Area under the glucose infusion rate curve (GIR)	10 hours
Secondary	Area under the insulin curve following inhalation of salbutamol	Area under the insulin curve following inhalation of salbutamol in subjects with asthma	10 hours