safety, tolerability and clinical activity of asm-024 in stable moderate asthma

Conditions: Asthma

Summary: the purpose of this study is to evaluate the safety, tolerability and clinical activity of asm-024 in stable moderate asthma.


Eligibility criteria:
inclusion criteria: * able and willing to provide written informed consent. * male or female subjects, ≥ 18 years and ≤ 55 years of age * diagnosis of moderate asthma and on regular inhaled corticosteroids with or without short or long-acting beta-2-agonists * fev1 ≥ 55 % predicted in the absence of medications for asthma * female subjects of childbearing potential must have a negative pregnancy test (serum beta-human chorionic gonadotropin (b-hcg)) at screening, and a negative pregnancy test immediately before the administration of the study drug for each of periods 1, 2 and 3. sexually active females with non-sterile partner must be willing to use adequate contraception. * male subjects must be willing to use a condom with a spermicide for the duration of their participation in the study, plus an additional 30 days following study drug administration and ensure that their partner is using a highly effective method of birth control such as combined oral contraceptives, implants, injectables or an intra-uterine device (iud). male subjects must ensure that their female partner is willing to use adequate contraception. * demonstration of an increase in fev1 by ≥ 10 % predicted between spirometry performed before and 10-20 minutes after the administration of 2 puffs of 100 micrograms of salbutamol at screening. 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).

Keywords: stable moderate asthma