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

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



Sponsors

Lead Sponsor


Collaborators



Source

Dance Biopharm Inc.

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

Yes

Is Fda Regulated Device

No


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.

Overall Status

Not yet recruiting

Start Date

2017-11-27

Completion Date

2018-07-17

Primary Completion Date

2018-05-31

Phase

Phase 1

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Area under the insulin curve (AUC)
10 hours
Area under the glucose infusion rate curve (GIR)
10 hours

Secondary Outcome

Measure

Time Frame

Area under the insulin curve following inhalation of salbutamol
10 hours

Enrollment

40

Condition


Intervention

Intervention Type

Drug

Intervention Name


Description

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

Arm Group Label

Dance 501

Other Name

Dance 501


Intervention Type

Drug

Intervention Name


Description

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

Arm Group Label

Insulin Lispro

Other Name

Lispro



Eligibility

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.

Gender

All

Minimum Age

30 Years

Maximum Age

70 Years

Healthy Volunteers

Accepts Healthy Volunteers


Overall Official

Last Name

Role

Affiliation

Dana A Yee, MD
Principal Investigator
WCCT Global

Overall Contact

Last Name

Lisa Porter, MD

Phone

858 344-6515

Email



Verification Date

2017-10-01

Lastchanged Date

2017-10-10

Firstreceived Date

2017-10-02

Responsible Party

Responsible Party Type

Sponsor


Keywords


Has Expanded Access

No

Number Of Arms

2

Intervention Browse

Mesh Term

Insulin, Globin Zinc

Insulin

Insulin Lispro



Arm Group

Arm Group Label

Dance 501

Arm Group Type

Experimental

Description

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


Arm Group Label

Insulin Lispro

Arm Group Type

Active Comparator

Description

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



Firstreceived Results Date

N/A

Overall Contact Backup

Last Name

Yu P Yen, PhD

Phone

414 235-2133

Email



Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Crossover Assignment

Intervention Model Description

Randomized, open-label, cross-over design

Primary Purpose

Treatment

Masking

None (Open Label)


Study First Submitted

October 2, 2017

Study First Submitted Qc

October 10, 2017

Study First Posted

October 11, 2017

Last Update Submitted

October 10, 2017

Last Update Submitted Qc

October 10, 2017

Last Update Posted

October 11, 2017


ClinicalTrials.gov processed this data on October 11, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



© 2017 ICH GCP