safety, tolerability and clinical activity of asm-024 in subjects with mild allergic asthma

Conditions: Mild Allergic Asthma

Summary: the study will assess the safety, tolerability and clinical activity of asm-024 in subjects with mild allergic asthma.


Eligibility criteria:
inclusion criteria: * able and willing to provide written informed consent; * male or female subjects, ≥18 years and ≤ 50 years of age; * female subjects of childbearing potential must have a negative pregnancy test (serum b-hcg) at pre-screening, and a negative urine pregnancy test immediately before the first administration of the study drug for each of the three treatment periods. sexually active females 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 a iud. male subjects must ensure that their female partner is willing to use adequate contraception; * diagnosis of mild allergic asthma that meets the following criteria: * stable on inhaled short-acting beta-2-agonists p.r.n. as the only medication for asthma. * presence of both early asthmatic response (ear) (at least 20 % fall in fev1 within 3 hours after allergen inhalation) and late asthmatic response (lar) (at least 15 % fall in fev1). * baseline methacholine (pc20) ≤ 16 mg/ml. * fev1 of at least 70 % of the predicted value at pre-screening and screening / baseline; * bmi ≥ 19 and ≤ 35 kg/m²; * body weight ≥ 40 kg; * positive skin prick test to at least one common aeroallergen. exclusion criteria: * any lung disease other than mild allergic asthma; * pregnant or nursing women or women intending to conceive during the course of the study or have a positive serum pregnancy test at pre-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. highly effective methods of birth control are defined as those which result in a low failure rate (i.e., less than 1 % per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, intra-uterine devices (iuds), sexual abstinence or a partner who has undergone a vasectomy; * respiratory tract infections or worsening of asthma within 6 weeks before screening/baseline; * baseline methacholine pc20 \> 16 mg/ml at screening / baseline; * current cigarette smokers or former smokers with a smoking history of greater than 10 pack years or who stopped smoking within the 12 months preceding enrolment in the study; * use of any nicotine containing products within 6 months before pre-screening; * any of the following concomitant medications: * any medication that are known to prolong qt / qtc interval. * oral or inhaled corticosteroids within 28 days preceding pre-screening or systemic corticosteroids within 90 days of pre-screening. * long acting beta-2-agonists within one week preceding baseline. * use of inhaled short-acting β2- agonists or anticholinergics within 8 hours before all study visits to the clinic. * known or suspected allergy or sensitivity to nicotine or cholinergic drugs or any drug with similar chemical structure; * clinically significant ecg abnormalities at pre-screening including clinically significant or marked baseline prolongation of qt / qtc interval (e.g. repeated demonstration of a qtc interval of \> 450 ms). other non clinically significant findings such as sinus bradycardia, sinus arrhythmia, borderline first degree av block (up to 205 ms), left ventricular hypertrophy (on voltage criteria for a subject less than 40 years old for instance) are permissible if judged to be acceptable by the qualified investigator; * family history of additional risk factors for tdp (e.g., family history of long qt syndrome.