Study to Assess the Efficacy of a Single PBF-680 Oral Administration to Attenuate Adenosine 5'-Monophosphate Challenge-induced Airway Hyperresponsiveness in Mild-to-moderate Asthmatics

Exclusion Criteria

• •Current smokers, smokers within six months prior to Visit 1, or subjects with an smoking history greater than 5 pack-years.
• •Asthmatics in treatment Step 5 as per GINA guidelines, including oral corticosteroids and/or omalizumab, or any immunosuppressive medication whether asthma-related or indicated for any concomitant morbidities.
• •Subjects with a history of life-threatening asthma attacks (i.e. requiring ICU admission, orotracheal intubation).
• •Subjects with a history of a respiratory tract infection or an asthma crisis requiring the use of antibiotics and/or systemic corticosteroids within 4 weeks prior to Visit 1, or who develop a respiratory tract infection or asthma crisis during the screening period. In the latter case, the subjects can be re-screened four weeks after the last dose of systemic corticosteroid or antibiotic.
• •Subjects that received bronchial thermoplastic treatment.
• •Subjects with concomitant pulmonary or thoracic disease other than asthma that could interfere safety or efficacy as per site investigator assessment. This includes, but is not limited to, COPD attributable to tobacco or alpha-1 antitrypsin deficiency, cystic fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, active pulmonary tuberculosis, or any prior condition that led to pulmonary resection surgery or lung transplantation. Non-cystic fibrosis bronchiectasis without clinically significant morbidity, moderate alpha-1 antitrypsin deficiency without evidence of emphysema or related COPD, or past pulmonary tuberculosis that received proper medical treatment, are acceptable provided that the condition is not expected to interfere with pulmonary function testing as per site investigator assessment.
• •Subjects with symptoms of angina pectoris or with a history of confirmed coronary disease or cardiomyopathy.
• •Subjects with A-V block in any degree, sinus bradycardia, tachyarrhythmia, unstable atrial fibrillation, long QT syndrome, QTc(F) interval greater than 450 ms at screening(Visit 2), or any other EKG abnormality deemed clinically significant by the investigator.
• •Subjects who have a clinically significant laboratory abnormality at screening (Visit 2).
• •Subjects with current uncontrolled arterial hypertension.
• •Women of child-bearing potential, unless they are surgically sterile (i.e. bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy), are at least 2 years postmenopausal, practice abstinence, or agree to employ effective contraception from Visit 1 through Visit 6. Acceptable contraception procedures are oral, transdermal, or implanted contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, or use of a condom with spermicide by the sexual partner.
• •Women supplying lactation.
• •Receipt of any investigational drug therapy or biologicals within 3 months before randomization in this study, or within 5 half-lives of the investigational agent or biologic, whichever is longer.
• •History of any known immunodeficiency disorder.
• •Subjects with a history of malignancy within the past five years, with the exception of localized basal cell carcinoma of the skin.
• •History of treatment for alcohol or drug abuse within the past year.
• •Subjects with any comorbidity that could affect the safety or efficacy as per site investigator assessment.