| 1. Provided written informed consent for the study prior to any study activities and is willing to comply with all requirements of the protocol BMI/Weight
2. Body mass index (BMI) ≥ 18.5 kg/m2 and < 35 kg/m2 at screening (weight ≥ 50 kg for males and ≥ 45 kg for females)
3. Diagnosis of COPD for at least 1 year according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria; or with a COPD history of ≥ 12 months at Screening supported by medical records
4. COPD with physician-confirmed diagnosis of chronic bronchitis
5. At least 2 moderate* or > 1 severe** exacerbation within 12 months prior to screening
6. Current or ex-tobacco smokers with history of ≥ 10 pack-years (1 pack year = 20 cigarettes smoked per day for 1 year);
7. Stable maintenance therapy with either dual or triple inhaled therapy for ≥ 3 months prior to enrollment per the protocol
8. Post–BD FEV1/FVC < 0.7 and post-BD FEV1(% predicted) ≥ 40% at Screening
9. COPD Assessment Test (CAT) score ≥ 10 at Screening
10. If participant is of childbearing potential, must commit to practicing highly effective methods of birth control and not donating eggs during the study and at least 14 days after the last dose.
11. Male participants commit to the following during the study - true sexual abstinence, use a condom, be vasectomized, refrain from donating sperm |
1. COPD exacerbation within the 4 weeks prior to randomization
2. Clinically important pulmonary disease other than COPD
3. Significant immunodeficiency and/or positive serological tests for hepatitis B, hepatitis C, or known human immunodeficiency virus (HIV) infection.
4. Pneumonia requiring antibiotics or antiviral medication within 28 days prior to Visit 1
5. History of clinically significant infection (excluding pneumonia), acute upper or lower respiratory infection
6. Evidence of active liver disease
7. Participants with a QT interval, from the ECG conducted at Screening Visit 1, corrected with Fridericia’s formula (QTcF) > 450 msec (or QTcF > 480 msec in participants with bundle branch block).
8. Current or history, within the past year of Visit 1, of substance and/or alcohol abuse.
9. History of cancer except: basal cell carcinoma, localized squamous cell carcinoma of the skin or in situ carcinoma of the cervix
10. Any clinically significant abnormal findings in physical examination, vital signs, hematology, clinical chemistry, or urinalysis during Screening Period
11. Known history of allergy or reaction to any component of the investigational product formulation.
12. Current treatment with biologic drugs for COPD (eg, dupilumab, mepolizumab) or use of biologics
13. Current long-term treatment with oxygen therapy > 12 hours per day
14. Newly initiated chronic therapy for COPD within 3 months before Screening in the previous 3 months.
15. Use of allergy immunotherapy.
16. Use of immunoglobulin or blood products in 30 days prior to Screening
17. Received a live attenuated vaccine within 30 days prior to Screening
18. Participating in the acute phase of a pulmonary rehabilitation program
19. Tooth Pain or infection or tooth extraction scheduled
20. Has active periodontal disease
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80 and over: 80+ Year,Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) |
40 Year(s) |
85 Year(s) |
Both |