Safety, Tolerability and Clinical Activity of ASM-024 in Stable Moderate Asthma

Exclusion Criteria

• •Clinically significant conditions or illnesses other than moderate asthma or systemic diseases
• •Pregnant or nursing women or women intending to conceive during the course of the study or have a positive serum pregnancy test at Screening or a positive urine pregnancy test during the study.
• •Women of childbearing potential (unless surgically sterilized by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years) not using a highly effective method of birth control.
• •Non-surgically sterile males and males with partners of childbearing potential not willing to use a condom with spermicide for the duration of their participation in the study plus an additional 30 days following study drug administration and to ensure that their partner is using a highly effective method of birth control such as combined oral contraceptives, implants, injectables or an IUD.
• •Respiratory tract infections or worsening of asthma or changes in asthma medications within 6 weeks before Screening/Baseline.
• •Current cigarette smokers or former smokers with a smoking history of greater than 10 pack years or who stopped smoking within 12 months preceding enrolment in the study.
• •Positive urine cotinine test at Screening.
• •History of illicit drug use or alcohol abuse within 12 months before Screening.
• •Positive test for Hepatitis B, Hepatitis C or Human Immunodeficiency Virus (HIV) at Screening.
• •Any medication that are known to prolong QT / QTc interval.
• •Any of the following concomitant medications preceding the administration of salbutamol during Screening and preceding the administration of the study drug:
• •* Oral or i.v. corticosteroids within 1 month;
• •* Inhaled or intranasal corticosteroids within 48 hours;
• •* Long acting Beta-2-agonists within 24 hours;
• •* Short acting Beta-2-agonists within 8 hours;
• •* Anticholinergic aerosols within 24 hours; and
• •* Theophylline-containing products within 48 hours.
• •Use of NSAIDs within 7 days preceding the administration of salbutamol during Screening and throughout the study.
• •Use of antihistaminic drugs within 3 days preceding the administration of salbutamol during Screening.
• •Use of an investigational product or participation in a clinical trial using an investigational product within 30 days before dosing or within 90 days in the case of long-acting products (ex.: Depo-medrol) or biologics with a long-acting half-life (ex.: monoclonal antibodies).