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

Phase 2

Terminated

• Conditions: Safety and Tolerability
• Interventions: Drug: inhaled human insulin; Drug: Insulin Lispro (Humalog U-100)

• Registration Number: NCT03307512
• Lead Sponsor: Dance Biopharm Inc.

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).

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 Timeline

• Study First Submitted: 2017-10-02
• Study First Submitted QC: 2017-10-10
• Study First Posted: 2017-10-11
• Study Start: 2018-02-06
• Primary Completion: 2019-07-30
• Study Completion: 2019-08-30
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-11
• Last Update Posted: 2019-09-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Area under the insulin curve following inhalation of salbutamol	10 hours	Area under the insulin curve following inhalation of salbutamol in subjects with asthma

Trial Locations

Locations (1)

WCCT; 🇺🇸 Cypress, California, United States