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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03307512

Enrollment

Registered

2017-10-11

Start date

2018-02-06

Completion date

2019-08-30

Last updated

2019-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Safety and Tolerability

Keywords

inhaled insulin, asthma, COPD

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.

Interventions

DRUGinhaled human insulin

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

DRUGInsulin Lispro (Humalog U-100)

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Randomized, open-label, cross-over design

Eligibility

Sex/Gender

ALL

Age

30 Years to 70 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026