Safety, Tolerability and Pharmacokinetics of ASM-024 Administered to Healthy Subjects and Subjects With Moderate Asthma

NCT01793298 | Terminated Phase 1

• 1 other identifier: ASM-024/I-II/STA-03
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• adverse events, spirometry

  up to 7 days

Study Arms (5)

Healthy Subjects - ASM-024 Single Administration

EXPERIMENTAL

Single administration of ascending doses of ASM-024

Drug: ASM-024

Healthy Subjects - Placebo

PLACEBO COMPARATOR

Single administration of placebo

Healthy Subjects - ASM-024 Repeat Administration

EXPERIMENTAL

Repeat administration of ascending doses of ASM-024

Drug: ASM-024

Healthy Subjects - Placebo Repeat Administration

PLACEBO COMPARATOR

Repeat administration of ascending doses of placebo

Subjects with Asthma

EXPERIMENTAL

Repeat administration of ascending doses of ASM-024 or placebo in a crossover fashion

Drug: ASM-024

Interventions

ASM-024 DRUG

Ascending doses of ASM-024

Healthy Subjects - ASM-024 Repeat Administration; Healthy Subjects - ASM-024 Single Administration; Subjects with Asthma

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Asmacure Ltée: lead

Study Sites (2)

PharmaNet

Québec, Quebec, G1P 0A2, Canada

Location

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

Location

MeSH Terms

Conditions

Asthma

Interventions

ASM-024

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Yvon Cormier, M.D.

  Asmacure Ltée

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2013
• First Posted: February 15, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 10, 2015

Record last verified: 2015-02

Locations

CA (2)