Created at Source Raw Value Validated value
June 25, 2024, noon usa

* any previous and/or current clinically significant disease or condition that has not been stable within 3 months prior to enrollment, or acute illness, planned medical/ surgical procedure, or any trauma that occurred within 2 weeks prior to enrollment. * chronic obstructive pulmonary disease (copd) patients requiring inhaled corticosteroid, long-acting beta-adrenergic agonists, long-acting anticholinergics, or long-term oxygen therapy (part 1 only). * pulmonary interstitial disease, pulmonary alveolar proteinosis, and pulmonary granulomatosis. * cardiovascular event in the 3 months prior to study drug administration: acute myocardial infarction or unstable angina pectoris, severe arrhythmia (multiple sources of frequent ventricular premature beat, ventricular tachycardia and ventricular fibrillation); new york heart association classification (nyha): class iii-class iv. * blood system disorders or routine blood analysis test abnormalities: hemoglobin \< 8 g/dl; absolute neutrophil count (anc) \<1500 × 109/l; platelets \< 50 × 109/l. * dependence on glucocorticoid treatment equivalent to methylprednisolone 2 mg/kg/ day or more or long-term use of anti-rejection or immunomodulatory drugs. * subjects that have been on invasive mechanical ventilation for ≥120 hours at the time of dosing * subjects that require ecmo. * pregnant or breastfeeding females.

* any previous and/or current clinically significant disease or condition that has not been stable within 3 months prior to enrollment, or acute illness, planned medical/ surgical procedure, or any trauma that occurred within 2 weeks prior to enrollment. * chronic obstructive pulmonary disease (copd) patients requiring inhaled corticosteroid, long-acting beta-adrenergic agonists, long-acting anticholinergics, or long-term oxygen therapy (part 1 only). * pulmonary interstitial disease, pulmonary alveolar proteinosis, and pulmonary granulomatosis. * cardiovascular event in the 3 months prior to study drug administration: acute myocardial infarction or unstable angina pectoris, severe arrhythmia (multiple sources of frequent ventricular premature beat, ventricular tachycardia and ventricular fibrillation); new york heart association classification (nyha): class iii-class iv. * blood system disorders or routine blood analysis test abnormalities: hemoglobin \< 8 g/dl; absolute neutrophil count (anc) \<1500 × 109/l; platelets \< 50 × 109/l. * dependence on glucocorticoid treatment equivalent to methylprednisolone 2 mg/kg/ day or more or long-term use of anti-rejection or immunomodulatory drugs. * subjects that have been on invasive mechanical ventilation for ≥120 hours at the time of dosing * subjects that require ecmo. * pregnant or breastfeeding females.

Nov. 3, 2020, 11:31 p.m. usa

- any previous and/or current clinically significant disease or condition that has not been stable within 3 months prior to enrollment, or acute illness, planned medical/ surgical procedure, or any trauma that occurred within 2 weeks prior to enrollment. - chronic obstructive pulmonary disease (copd) patients requiring inhaled corticosteroid, long-acting beta-adrenergic agonists, long-acting anticholinergics, or long-term oxygen therapy (part 1 only). - pulmonary interstitial disease, pulmonary alveolar proteinosis, and pulmonary granulomatosis. - cardiovascular event in the 3 months prior to study drug administration: acute myocardial infarction or unstable angina pectoris, severe arrhythmia (multiple sources of frequent ventricular premature beat, ventricular tachycardia and ventricular fibrillation); new york heart association classification (nyha): class iii-class iv. - blood system disorders or routine blood analysis test abnormalities: hemoglobin < 8 g/dl; absolute neutrophil count (anc) <1500 × 109/l; platelets < 50 × 109/l. - dependence on glucocorticoid treatment equivalent to methylprednisolone 2 mg/kg/ day or more or long-term use of anti-rejection or immunomodulatory drugs. - subjects that have been on invasive mechanical ventilation for ≥120 hours at the time of dosing - subjects that require ecmo. - pregnant or breastfeeding females.

- any previous and/or current clinically significant disease or condition that has not been stable within 3 months prior to enrollment, or acute illness, planned medical/ surgical procedure, or any trauma that occurred within 2 weeks prior to enrollment. - chronic obstructive pulmonary disease (copd) patients requiring inhaled corticosteroid, long-acting beta-adrenergic agonists, long-acting anticholinergics, or long-term oxygen therapy (part 1 only). - pulmonary interstitial disease, pulmonary alveolar proteinosis, and pulmonary granulomatosis. - cardiovascular event in the 3 months prior to study drug administration: acute myocardial infarction or unstable angina pectoris, severe arrhythmia (multiple sources of frequent ventricular premature beat, ventricular tachycardia and ventricular fibrillation); new york heart association classification (nyha): class iii-class iv. - blood system disorders or routine blood analysis test abnormalities: hemoglobin < 8 g/dl; absolute neutrophil count (anc) <1500 × 109/l; platelets < 50 × 109/l. - dependence on glucocorticoid treatment equivalent to methylprednisolone 2 mg/kg/ day or more or long-term use of anti-rejection or immunomodulatory drugs. - subjects that have been on invasive mechanical ventilation for ≥120 hours at the time of dosing - subjects that require ecmo. - pregnant or breastfeeding females.

Oct. 26, 2020, 11:31 p.m. usa

- any previous and/or current clinically significant disease or condition that has not been stable within 3 months prior to enrollment, or acute illness, planned medical/ surgical procedure, or any trauma that occurred within 2 weeks prior to enrollment. - chronic obstructive pulmonary disease (copd) patients requiring inhaled corticosteroid, long-acting beta-adrenergic agonists, long-acting anticholinergics, or long-term oxygen therapy. - pulmonary interstitial disease, pulmonary alveolar proteinosis, and pulmonary granulomatosis. - cardiovascular event in the 3 months prior to study drug administration: acute myocardial infarction or unstable angina pectoris, severe arrhythmia (multiple sources of frequent ventricular premature beat, ventricular tachycardia and ventricular fibrillation); new york heart association classification (nyha): class iii-class iv. - blood system disorders or routine blood analysis test abnormalities: hemoglobin < 8 g/dl; absolute neutrophil count (anc) <1500 × 109/l; platelets < 50 × 109/l. - dependence on glucocorticoid treatment equivalent to methylprednisolone 2 mg/kg/ day or more or long-term use of anti-rejection or immunomodulatory drugs. - subjects that require ecmo. - pregnant or breastfeeding females.

- any previous and/or current clinically significant disease or condition that has not been stable within 3 months prior to enrollment, or acute illness, planned medical/ surgical procedure, or any trauma that occurred within 2 weeks prior to enrollment. - chronic obstructive pulmonary disease (copd) patients requiring inhaled corticosteroid, long-acting beta-adrenergic agonists, long-acting anticholinergics, or long-term oxygen therapy. - pulmonary interstitial disease, pulmonary alveolar proteinosis, and pulmonary granulomatosis. - cardiovascular event in the 3 months prior to study drug administration: acute myocardial infarction or unstable angina pectoris, severe arrhythmia (multiple sources of frequent ventricular premature beat, ventricular tachycardia and ventricular fibrillation); new york heart association classification (nyha): class iii-class iv. - blood system disorders or routine blood analysis test abnormalities: hemoglobin < 8 g/dl; absolute neutrophil count (anc) <1500 × 109/l; platelets < 50 × 109/l. - dependence on glucocorticoid treatment equivalent to methylprednisolone 2 mg/kg/ day or more or long-term use of anti-rejection or immunomodulatory drugs. - subjects that require ecmo. - pregnant or breastfeeding females.