Clinical trial NCT01743768 (phase 2, status: completed)
Conditions: asthma
ICD codes: J45.998, J82.83, J45.909, J45.991, J45.20, J45.30, J45.40
Drugs: sb010, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          1. Adult male Caucasian patients aged ≥ 18 and ≤ 60 years.

          2. Clinical diagnosis of mild asthma (according to GINA guidelines 2008 update) for at
             least 6 months prior to screening. No concomitant asthma treatment. except inhaled
             short-acting bronchodilators.

          3. Screening FEV1 value of FEV1 ≥ 70 % of the predicted normal value (ECSC) after a wash
             out of at least 6 hours for inhaled short-acting bronchodilators,

          4. Patient must demonstrate sufficient induced sputum production.

          5. Positive skin prick test (skin reactivity) to common aeroallergens (e.g. animal
             epithelia, dust mite).

          6. Patient must demonstrate positive allergen-induced early- and late-phase airway
             bronchoconstriction.

          7. At all timepoints before AC and MCh, patients must show FEV1 not below 65 % predicted.

          8. Presence of sputum eosinophils either before or after screening allergen challenge
             (first or second induced sputum).

          9. Patient has been informed both verbally and in writing about the objectives of the
             clinical trial, the methods, the anticipated benefits and potential risks and the
             discomfort to which he may be exposed, and has given written consent to participation
             in the trial prior to trial start and any trial-related procedure.

         10. Patient is able to understand and give written informed consent and has signed a
             written informed consent form approved by the Investigator's Research Ethics Board.

         11. Non-smokers or ex-smokers who had stopped smoking for at least 1 year prior to start
             of the clinical study with < 10 pack years.

         12. Ability to inhale in an appropriate manner (patients will be trained to inhale from
             the AKITA2 APIXNEB® device with a placebo medication at the screening visit).

         13. Only men who do not want to father children for six months after the last dose of
             SB010 will be included into this study.

        Exclusion Criteria:

          1. Presence of clinically significant diseases other than asthma (cardiovascular, renal,
             hepatic, gastrointestinal, haematological, neurological, genitourinary, autoimmune,
             endocrine, metabolic, etc.), which, in the opinion of the investigator, may either put
             the patient at risk because of participation in the trial, or diseases which may
             influence the results of the study or the patient's ability to take part in it.

          2. Presence of relevant pulmonary diseases or history of thoracic surgery, such as:

               -  known active tuberculosis,

               -  History of interstitial lung or pulmonary thromboembolic disease,

               -  Pulmonary resection during the past 12 months,

               -  History of status asthmaticus,

               -  History of bronchiectasis secondary to respiratory diseases (e.g. cystic
                  fibrosis, Kartagener's syndrome, etc.),

               -  History of chronic bronchitis, emphysema, allergic bronchopulmonary aspergillosis
                  or respiratory infection within the 4 preceding weeks of the first morning IMP
                  administration.

          3. Patients on concomitant treatments, except for inhaled short-acting bronchodilators as
             judged by the investigator.

          4. Use of short-acting ß2-agonists 6 hours before study visits 2, 3, 4, 5, 11, and 12.

          5. Hospitalisation or emergency room treatment for acute asthma in the 6 months prior to
             screening, between screening and the start of the treatment period.

          6. Intubation (ever) or hospitalisation for longer than 24 hours for the management of an
             asthma exacerbation within the preceding 6 months of the screening visit.

          7. History or current evidence of clinically relevant allergies or idiosyncrasy to drugs.

          8. History of allergic reactions to any active or inactive ingredients of the nebuliser
             solution.

          9. ECG abnormalities of clinical relevance.

         10. Subjects with a resting heart rate < 45 bpm, systolic blood pressure < 100 mmHg,
             diastolic blood pressure < 60 mmHg.

         11. Proneness to orthostatic dysregulation, fainting, or blackouts.

         12. History of malignancy within the past 5 years, except excised basaliomas.

         13. Clinically relevant abnormalities in clinical chemical, haematological or in any other
             laboratory variables as judged by the investigator.

         14. Clinically relevant acute infections in the last 4 weeks preceding AC.

         15. Clinically relevant chronic infections.

         16. Positive results in any of the virology tests of acute or chronic infectious human
             immunodeficiency virus (HIV) and hepatitis B/C virus infections.

         17. Positive drug screen.

         18. Abuse of alcohol or drugs.

         19. Positive cotinine test.

         20. Treatment with any known enzyme inducing or inhibiting agents (St. John's Wort
             (Johanniskraut), barbiturates, phenothiazines, cimetidine, ketoconazole etc.) within
             30 days before first administration of trial medication or during treatment period of
             the trial.

         21. Use of any prohibited concomitant medication within 2 weeks (for biologics: 6 months
             or 10 times the elimination half-life of the respective drug) before first trial
             medication administration or within < 10 times the elimination half-life of the
             respective drug, or the duration of the pharmacodynamic effect, whatever is longer, or
             anticipated concomitant medication during the treatment period.

         22. Consumption of any enzyme inducing or inhibiting aliments and beverages (e.g.
             broccoli, Brussels sprout, grapefruit, grapefruit juice, star fruit etc.) within 14
             days prior to the first trial medication administration and during the treatment
             period of the trial.

         23. Consumption of any caffeine-containing product 6 hours before first procedure at each
             study visit.

         24. Surgery of the gastrointestinal tract which may interfere with drug absorption of
             swallowed fraction (Note: this is not applicable for minor abdominal surgery such as
             appendectomy or herniotomy).

         25. Blood donation within the last 30 days before screening.

         26. Planned donation of germ cells, blood, organs or bone marrow during the course of the
             trial or within 6 months thereafter.

         27. Participation in another clinical trial with an investigational drug or device within
             the last month or within 10 times the half-life of the respective drug. For biologics
             the minimum period is at least 6 months or the time of duration of the pharmacodynamic
             effect or 10 times the half-life of the respective drug before inclusion in this
             trial.

         28. Lack of ability or willingness to give informed consent or inability to cooperate
             adequately.

         29. Anticipated non-availability for trial visits/procedures.

         30. Vulnerable subjects (e.g., persons kept in detention).

         31. Employee at the investigational site, relative or spouse of the investigator.