Clinical trial NCT02334553 (phase 2, status: completed)
Conditions: asthma
ICD codes: J45.998, J82.83, J45.909, J45.991, J45.20, J45.30, J45.40
Drugs: s1226(8%), placebo
SMILES: FC(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)C(F)(F)Br, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          1. Male or female subjects 18-40 years of age.

          2. BMI of 18-40 kg/m2

          3. Subject is not currently on topical or systemic corticosteroids and has not taken any
             oral/injectable corticosteroid within 60 days prior to study drug administration and
             has not used any inhaled/nasal corticosteroid within 30 days prior to study drug
             administration.

          4. Female subjects must not be pregnant or lactating and must be practicing an acceptable
             method of birth control, or be surgically sterile or postmenopausal.

          5. Subjects must have had asthma for at least 3 months.

          6. Subject is a non-smoker or has not smoked for > 1year and has < 10 pack-year history.

          7. Subject has a methacholine PC20 of less than 16mg/mL.

          8. Subject has normal laboratory values (normal values as clinically judged by the
             Investigator) for clinical chemistry, hematology, and urinalysis.

          9. Subject is in general good health based on medical history and clinically acceptable
             results for the following assessments: physical examination, vital signs, and 12-lead
             ECG, as assessed by study physicians.

         10. Subject is able to communicate effectively with study personnel and is reliable,
             willing and cooperative in terms of compliance with protocol.

        Exclusion Criteria:

        Subjects to whom any of the following applies will be excluded from the study:

          1. Any clinically significant abnormality or abnormal laboratory test results found
             during medical screening or positive test for hepatitis B, hepatitis C, or HIV found
             during medical screening.

          2. Subjects who require inhaled β2-agonist medication more frequently than 4 times a week
             (other than prophylactically prior to exercise) during the 4 week period before
             screening.

          3. Subjects who are currently treated with any asthma medication other than inhaled
             β2-agonist.

          4. Subjects with frequent emergency room visits for asthma, with prior ICU admission or
             those with prior intubation.

          5. Presence or history of neurologic, endocrine, hepatic, gastrointestinal or kidney
             disease or therapy that would jeopardize the subject's well-being by participating in
             the study.

          6. Cardiovascular disease that, in the opinion of the Investigator, is not stable or
             could put the subject at increased risk by participating in the study.

          7. Any reason which, in the opinion of the Investigator (or delegate), would prevent the
             subject from participating in the study.

          8. Clinically significant electrocardiogram (ECG) abnormalities or vital sign
             abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood
             pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at
             screening.

          9. Subject has a history of physician diagnosed panic disorder or other anxiety
             disorders.

         10. Subject is currently receiving treatment, or has received treatment in the previous 14
             days, with monoamine oxidase (MAO) inhibitors.

         11. Subjects dosed with an investigational drug within 30 days prior to the Screening
             Visit.

         12. Subjects dosed with biologic therapy within the previous 4 months or 5 half-lives from
             baseline methacholine testing.

         13. Subject has current (or within the last six months) evidence of alcohol abuse
             (regularly drinks more than 4 units of alcohol per day; 1 unit = ½ pint of beer, 1
             glass of wine, or 1 ounce of spirit)

         14. Positive urine drug screen or urine cotinine test at screening.

         15. Breast-feeding subject.

         16. Positive pregnancy test at screening.

         17. Subject, who in the opinion of the Investigator, is mentally or emotionally unsuitable
             to participate, or unable/unwilling to comply with the study assessments.