NCT03307512

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Dance Biopharm Inc. · Industry
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Accepted

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).

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.

Conditions

• Safety and Tolerability

Interventions

Type	Name	Description
DRUG	inhaled human insulin	Dance 501 (Human Insulin Inhalation Solution and Inhaler) will be administered by inhalation
DRUG	Insulin Lispro (Humalog U-100)	Insulin Lispro (Humalog U-100) will be administered by subcutaneous injection

Timeline

• Start date: 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 across 1 country: United States

Regulatory

• FDA-regulated drug study