Clinical trial NCT02257177 (phase 1/phase 2, status: completed)
Conditions: idiopathic pulmonary fibrosis
ICD codes: J84.112
Drugs: inhaled td139, placebo
SMILES: OC[C@H]1O[C@@H](S[C@@H]2O[C@H](CO)[C@H](O)[C@@H]([C@H]2O)N2C=C(N=N2)C2=CC=CC(F)=C2)[C@H](O)[C@H]([C@H]1O)N1C=C(N=N1)C1=CC(F)=CC=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Male subject or female subject of non child-bearing potential with IPF.

          -  Subjects aged between 45 and 85 years of age.

          -  Subjects with an FVC (Forced Vital Capacity) ≥ 45% predicted and an FEV1 (Forced
             Expiratory Flow) /FVC ratio ≥ 0.7.

          -  Subjects with oxygen saturation >90% by pulse oximetry while breathing ambient air at
             rest.

          -  Subjects with a diffusing capacity (DLCO - transfer fact of the lung for carbon
             monoxide) >25%.

          -  Subjects with a diagnosis consistent with IPF prior to screening based on
             ATS/ERS/JRS/ALAT (American, European, Japanese and Latin American Respiratory
             Societies) consensus criteria.

          -  Subjects who are able to undergo bronchoalveolar lavage (BAL).

          -  Subjects able to provide written informed consent to participate in the study.

          -  Subjects with negative human immunodeficiency virus (HIV) and hepatitis B surface
             antigen (Hep B) and hepatitis C virus antibody (Hep C) results.

          -  Subjects with no clinically significant abnormalities in 12-lead electrocardiogram
             (ECG) determined within 28 days of the first dose.

          -  Subjects with a negative urinary drugs of abuse screen, determined within 28 days of
             the first dose.

        Exclusion Criteria:

          -  Any condition that makes the patient at unacceptable risk for bronchoscopy.

          -  Active cigarette smoking.

          -  Presence of a significant co-morbidity felt to limit life expectancy to less than 12
             months.

          -  HRCT (high resolution CT scan) pattern showing emphysema more than the extent of
             fibrosis of the lung area conducted within 12 months of Day 1.

          -  Evidence of renal, hepatic, central nervous system, or metabolic dysfunction.

          -  Evidence of poorly controlled diabetes mellitus (defined as a HbA1c of > 59 mmol/mol
             [7.5%]).

          -  Use of systemic immunosuppressants within 30 days of dosing.

          -  Subjects currently receiving oral corticosteroids, cytotoxic drugs (e.g. chlorambucil,
             azathioprine, cyclophosphamide, methotrexate), antifibrotic drugs (e.g. pirfenidone),
             vasodilator therapies for pulmonary hypertension (e.g bosentan), unapproved (e.g.
             Interferon-γ, penicillamine, cyclosporine, mycophenolate) and/or investigational
             therapies for IPF or administration of such therapies within 4 weeks of initial
             screening.

          -  History of malignancy, including carcinoma during the preceding five years.

          -  History of, or current asthma.

          -  Participation in a clinical study of an unlicensed drug in the previous 4 months, or a
             marketed drug study within the previous 3 months.