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

September 11, 2019 updated by: Dance Biopharm Inc.

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Cypress, California, United States, 90630
        • WCCT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Dance 501
Dance 501(Human Insulin Inhalation Solution and Inhaler) will be administered by inhalation
Drug: inhaled human insulin
Dance 501 (Human Insulin Inhalation Solution and Inhaler) will be administered by inhalation
Other Names:
  • Dance 501
ACTIVE_COMPARATOR: Insulin Lispro
Insulin Lispro (Humalog®) will be administered by subcutaneous injection
Drug: Insulin Lispro (Humalog U-100)
Insulin Lispro (Humalog U-100) will be administered by subcutaneous injection
Other Names:
  • Lispro

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the insulin curve (AUC)
Time Frame: 10 hours
Area under the insulin curve (AUC)
10 hours
Area under the glucose infusion rate curve (GIR)
Time Frame: 10 hours
Area under the glucose infusion rate curve (GIR)
10 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the insulin curve following inhalation of salbutamol
Time Frame: 10 hours
Area under the insulin curve following inhalation of salbutamol in subjects with asthma
10 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dance Biopharm Inc.

Collaborators

WCCT Global

Investigators

  • Principal Investigator: Timothy S Bailey, MD, AMCR

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 6, 2018

Primary Completion (ACTUAL)

July 30, 2019

Study Completion (ACTUAL)

August 30, 2019

Study Registration Dates

First Submitted

October 2, 2017

First Submitted That Met QC Criteria

October 10, 2017

First Posted (ACTUAL)

October 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 13, 2019

Last Update Submitted That Met QC Criteria

September 11, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Samba-AC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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