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

NCT03307512 — Phase 2, Terminated, 40 participants, Dance Biopharm Inc.

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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

Registry	NCT03307512
Status	Terminated - Termination due to incomplete enrollment; planned data analysis not performed
Phase	Phase 2
Study type	Interventional; randomized, crossover, masking: none, treatment
Enrollment	40 (Actual)
Sponsor	Dance Biopharm Inc. (Industry); collaborators: WCCT Global
Conditions	Safety and Tolerability
Interventions	inhaled human insulin, Insulin Lispro (Humalog U-100) (Drug)
Dates	start 2018-02-06, primary completion 2019-07-30, completion 2019-08-30, first posted 2017-10-11, last updated 2019-09-13
Locations	1 site in United States

-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).

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Dance 501	Experimental	Drug: inhaled human insulin	Dance 501(Human Insulin Inhalation Solution and Inhaler) will be administered by inhalation
Insulin Lispro	Active comparator	Drug: Insulin Lispro (Humalog U-100)	Insulin Lispro (Humalog®) will be administered by subcutaneous injection

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

+Outcome measures

Primary outcomes

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 outcomes

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

Sex: All, ages: 30 Years to 70 Years, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
WCCT	Cypress, California	United States

+Investigators

Timothy S Bailey, MD, Principal investigator, AMCR

My Notes

Public

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