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

NCT03307512 | Terminated Phase 2 FDA Drug

• 1 other identifier: Samba-AC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Safety and Tolerability

Keywords

inhaled insulin; asthma; COPD

Outcome Measures

Primary Outcomes (2)

• Area under the insulin curve (AUC)

  Area under the insulin curve (AUC)

  10 hours

• Area under the glucose infusion rate curve (GIR)

  Area under the glucose infusion rate curve (GIR)

  10 hours

Secondary Outcomes (1)

• Area under the insulin curve following inhalation of salbutamol

  10 hours

Study Arms (2)

Dance 501

EXPERIMENTAL

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

Drug: inhaled human insulin

Insulin Lispro

ACTIVE COMPARATOR

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

Drug: Insulin Lispro (Humalog U-100)

Interventions

inhaled human insulin DRUG

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

Also known as: Dance 501

Dance 501

Insulin Lispro (Humalog U-100) DRUG

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

Also known as: Lispro

Insulin Lispro

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dance Biopharm Inc.: lead
• WCCT Global: collaborator

Study Sites (1)

WCCT

Cypress, California, 90630, United States

Location

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive

Interventions

Insulin Lispro

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Timothy S Bailey, MD

  AMCR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, open-label, cross-over design

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: October 11, 2017
• Study Start: February 6, 2018
• Primary Completion: July 30, 2019
• Study Completion: August 30, 2019
• Last Updated: September 13, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)