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

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ClinicalTrials.gov Identifier: NCT03307512
Recruitment Status : Recruiting
First Posted : October 11, 2017
Last Update Posted : February 26, 2019
Sponsor:
Collaborator:
WCCT Global
Information provided by (Responsible Party):
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).


Condition or disease Intervention/treatment Phase
Safety and Tolerability Drug: inhaled human insulin Drug: Insulin Lispro (Humalog U-100) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized, open-label, cross-over design
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 6, 2018
Estimated Primary Completion Date : July 30, 2019
Estimated Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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 Name: 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 Name: Lispro




Primary Outcome Measures :
  1. Area under the insulin curve (AUC) [ Time Frame: 10 hours ]
    Area under the insulin curve (AUC)

  2. Area under the glucose infusion rate curve (GIR) [ Time Frame: 10 hours ]
    Area under the glucose infusion rate curve (GIR)


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03307512


Contacts
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Contact: Debbie D Tranowski (650)269-6287 dtranowski@dancebiopharm.com
Contact: Ryan S Patton (415)420-5629 rpatton@dancebiopharm.com

Locations
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United States, California
WCCT Recruiting
Cypress, California, United States, 90630
Contact: Emely Nguyen, MS,CCRP    714-252-0700 ext 1047    emely.nguyen@wcct.com   
Contact: Neil Patel, MBA    (714) 252-0700 ext 1111    neil.patel@wcct.com   
Sponsors and Collaborators
Dance Biopharm Inc.
WCCT Global
Investigators
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Principal Investigator: Timothy S Bailey, MD AMCR

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Responsible Party: Dance Biopharm Inc.
ClinicalTrials.gov Identifier: NCT03307512     History of Changes
Other Study ID Numbers: Samba-AC
First Posted: October 11, 2017    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dance Biopharm Inc.:
inhaled insulin
asthma
COPD

Additional relevant MeSH terms:
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Insulin
Insulin, Globin Zinc
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs