- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01793298
Safety, Tolerability and Pharmacokinetics of ASM-024 Administered to Healthy Subjects and Subjects With Moderate Asthma
February 9, 2015 updated by: Asmacure Ltée
A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of ASM-024 Administered by Dry Powder Inhalation to Healthy Subjects and Subjects With Stable Moderate Asthma
The purpose of this study is to evaluate the safety and tolerability of the dry powder formulation of ASM-024 following single and multiple administration by inhalation of ascending doses in healthy subjects and subjects with stable moderate asthma.
Study Overview
Detailed Description
This is a phase I/II, randomized, double-blind, placebo-controlled study of single ascending and multiple ascending doses of ASM-024 administered by dry powder inhalation to healthy subjects and subjects with stable moderate asthma.
The goal of this study is to evaluate the safety, tolerability and pharmacokinetic profile of a new, dry powder formulation of ASM-024.
The doses that will be tested in subjects with asthma will be determined based on the information collected first in healthy volunteers.
In addition to standard safety and tolerability evaluations, the acute effects of the study medication on the airways will be assessed.
Study Type
Interventional
Enrollment (Actual)
55
Phase
- Phase 2
- Phase 1
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
-
-
Quebec
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Québec, Quebec, Canada, G1V 4G5
- Institut Universitaire De Cardiologie Et De Pneumologie De Québec
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Québec, Quebec, Canada, G1P 0A2
- PharmaNet
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-
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
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
Healthy Volunteers:
- Healthy male or female adult, 18 to 55 years of age ; non-smoker or former smoker;
- Normal lung function; and
- Normal 12-lead ECG
Asthmatics:
- Male or female adult, 18 to 60 years of age with diagnosis of moderate asthma according to the GINA Guidelines and on regular inhaled corticosteroids with or without short or long-acting beta 2-agonists;
- Non-smoker or former smoker;
- FEV1 ≥ 70 % predicted in the absence of medications for asthma;
- Baseline methacholine PC20 ≤ 16 mg/mL; and
- Normal 12-lead ECG.
Exclusion Criteria:
Healthy Volunteers:
- Clinically significant illness or surgery within 8 weeks prior to first administration of the study medication;
- Significant medical history that, in the Investigator's opinion, may adversely affect participation;
- History of allergy or significant adverse reaction to drugs similar to ASM-024, to nicotine, or to cholinergic drugs or any drugs with a similar chemical structure;
- History of hypersensitivity (anaphylaxis, angioedema) to any drug;
- Use of any drug known to induce or inhibit hepatic drug metabolism, within 30 days prior to first administration of the study medication;
- Positive pregnancy test for female subjects;
- Use of medications known to prolong QT/QTc interval within 14 days prior to the first administration of the study medication;
- Clinically significant 12 lead ECG abnormalities at Screening;;
- Clinically significant physical examination or laboratory findings at Screening;
- History of alcohol or drug abuse;
- Tobacco use within 12 months prior to Screening, or nicotine-containing products within 6 months prior to Screening. History of smoking must be ≤ 10 pack-years;
- Positive hepatitis B or C or HIV test at Screening;
- Investigational drug within 30 days prior to first administration of the study medication, or long-acting investigational drug within 90 days prior to first administration of the study medication;
- Previous exposure to ASM-024; and
- Women of child-bearing potential and male participants unwilling or unable to use accepted methods of birth control.
Asthmatics:
- Clinically significant illness or surgery within 8 weeks prior to first administration of the study medication;
- Significant medical history that, in the Investigator's opinion, may adversely affect participation;
- History of allergy or significant adverse reaction to drugs similar to ASM-024, to nicotine, or to cholinergic drugs or any drugs with a similar chemical structure;
- History of hypersensitivity (anaphylaxis, angioedema) to any drug;
- Use of any drug known to induce or inhibit hepatic drug metabolism, within 30 days prior to first administration of the study medication;
- Positive pregnancy test for female subjects;
- Use of medications known to prolong QT/QTc interval;
- Clinically significant 12 lead ECG at Screening;
- Clinically significant physical examination or laboratory findings or abnormal vital signs;
- Baseline methacholine PC20 > 16 mg/mL at Screening;
- History of illicit drug use or alcohol abuse within 12 months of Screening;
- Tobacco use within 12 months prior to Screening, or nicotine-containing products within 6 months prior to Screening. History of smoking must be ≤ 10 pack-years;
- Positive hepatitis B or C or HIV test at Screening;
- Any of the following concomitant medications preceding the administration of methacholine during Screening and preceding the administration of the study medication at Visit 1: (i) oral or i.v. corticosteroids within 1 month; (ii) inhaled or intranasal corticosteroids within 48 hours; (iii) long-acting beta-2-agonists within 48 hours; (iv) short-acting beta-2-agonists within 8 hours; (v) anticholinergic aerosol within 24 hours; (vi) theophyline-containing products within 48 hours; (vii) NSAIDs within 7 days preceding the administration of methacholine during Screening and throughout the study; and (viii) antihistaminic drugs within 3 days;
- Investigational drug within 30 days of Screening; long-acting investigational drug within 90 days of Screening;
- Previous exposure to ASM-024; and
- Women of child-bearing potential and male participants unwilling or unable to use accepted methods of birth control.
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 Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Healthy Subjects - ASM-024 Single Administration
Single administration of ascending doses of ASM-024
|
Ascending doses of ASM-024
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Placebo Comparator: Healthy Subjects - Placebo
Single administration of placebo
|
|
Experimental: Healthy Subjects - ASM-024 Repeat Administration
Repeat administration of ascending doses of ASM-024
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Ascending doses of ASM-024
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Placebo Comparator: Healthy Subjects - Placebo Repeat Administration
Repeat administration of ascending doses of placebo
|
|
Experimental: Subjects with Asthma
Repeat administration of ascending doses of ASM-024 or placebo in a crossover fashion
|
Ascending doses of ASM-024
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
adverse events, spirometry
Time Frame: up to 7 days
|
up to 7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Yvon Cormier, M.D., Asmacure Ltée
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
March 1, 2013
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
February 14, 2013
First Submitted That Met QC Criteria
February 14, 2013
First Posted (Estimate)
February 15, 2013
Study Record Updates
Last Update Posted (Estimate)
February 10, 2015
Last Update Submitted That Met QC Criteria
February 9, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASM-024/I-II/STA-03
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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