Evaluation of Pharmacokinetics and Safety of A006 in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-03-31

Brief Summary

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The objective of this study is to evaluate the pharmacokinetics (PK) and safety profiles of A006, an Albuterol dry powder inhaler (DPI), following a single dose of 110 mcg (T1) or 220 mcg (T2), in healthy male and female adult volunteers.

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Detailed Description

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This study is a randomized, double or evaluator-blinded, single dose, four-arm, crossover PK study in eighteen (18) healthy volunteers, both male and female adults, at 18-40 years of age.

All candidates will be screened and only those who satisfy all enrollment criteria will be enrolled into this study. Each study subject will participate in a screening visit and four (4) study visits with one (1) randomized study treatment given in each visit.

PK samples will be analyzed with an established LC/MS/MS method. An End-of-Study (EOS) safety evaluation will be conducted at the end of Study Visit-4.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment T1

One inhalation of 110 mcg A006 DPI. Total 110 mcg

Group Type EXPERIMENTAL

A006 DPI

Intervention Type DRUG

Single dose 110 mcg, 1 inhalation

Treatment T2

One inhalation of 220 mcg A006 DPI. Total 220 mcg.

Group Type EXPERIMENTAL

A006 DPI

Intervention Type DRUG

Single dose 220 mcg, 1 inhalation

Treatment R1

One inhalation of 90 mcg Proventil® MDI. Total 90 mcg.

Group Type ACTIVE_COMPARATOR

Proventil® MDI

Intervention Type DRUG

Single dose 90 mcg, 1 inhalation

Treatment R2

Two inhalations of 90 mcg Proventil® MDI. Total 180 mcg

Group Type ACTIVE_COMPARATOR

Proventil® MDI

Intervention Type DRUG

Single dose 90 mcg, 2 inhalations

Interventions

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A006 DPI

Single dose 110 mcg, 1 inhalation

Intervention Type DRUG

A006 DPI

Single dose 220 mcg, 1 inhalation

Intervention Type DRUG

Proventil® MDI

Single dose 90 mcg, 1 inhalation

Intervention Type DRUG

Proventil® MDI

Single dose 90 mcg, 2 inhalations

Intervention Type DRUG

Other Intervention Names

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Albuterol Albuterol DPI Albuterol Albuterol DPI Proventil® Proventil®

Eligibility Criteria

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Inclusion Criteria

* Generally healthy, male and female adults, 18-40 years of age at Screening;
* Having no clinically significant respiratory, cardiovascular and other systemic or organic illnesses;
* Body weight ≥ 50 kg for men and ≥ 45 kg for women, and BMI within the range of 18.5 - 30.0 kg/m2 inclusive;
* Sitting blood pressure ≤ 135/90 mmHg;
* Demonstrating negative HIV, HBsAg and HCV tests, alcohol and nine panel urine drug screen tests;
* Demonstrating proficiency in the use of DPI and MDI or able to be trained in the proper use of these devices;
* Demonstrating Peak Inspiratory Flow Rate (PIF) within 80-150 L/min (after training), for at least 2 times consecutively, with a maximum of 5 attempts;
* Having no known hypersensitivity to any ingredients of A006 and Proventil® MDI (Albuterol, sulfate, lactose, milk protein, HFA-134a, oleic acid, or ethanol). (Subjects must be able to tolerate at least one teaspoon of milk);
* Women of child-bearing potential must be non-pregnant, non-lactating, and practicing a clinically acceptable form of birth control; and

Exclusion Criteria

* A smoking history of ≥ 5 pack-years, or having smoked within 6 months prior to Screening;
* Upper respiratory tract infections within 2 weeks, or lower respiratory tract infection within 4 weeks, prior to Screening;
* Previous history of asthma or COPD;
* Any current or recent respiratory conditions that, per investigator discretion, might significantly affect pharmacodynamic response to the study drugs, including cystic fibrosis, bronchiectasis, tuberculosis, emphysema, and other significant respiratory diseases;
* Concurrent clinically significant cardiovascular, hematological, renal, neurologic, hepatic, endocrine, psychiatric, malignant, or other illnesses that in the opinion of the investigator could impact on the conduct, safety and evaluation of the study;
* ECG at Screening and Visit-1 baseline expressed any single or multiple premature ventricular contractions (PVC);
* ECG at Screening and Visit-1 baseline with a QTc reading greater than 450ms;
* Use of prohibited drugs or failure to observe the drug washout restrictions; and
* Having been on other clinical drug/device studies or donated blood in the last 30 days prior to Screening.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes