RecruitingPulmonary Disease, Chronic Obstructive (COPD)

Evaluation of 611 in Chinese Adults Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Eligible age

40–85 yrs

Accepts

All genders

Locations

0 states

Healthy volunteers

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The objective of the study was to evaluate the efficacy and safety of 611 in Chinese adults with moderate to severe COPD.

Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

✓ 1. Able to understand and follow the protocol requirements, and give written informed consent prior to participation voluntarily in the study.
✓ 2. Male or female adults ages 40 to 85 years old when signing the informed consent.
✓ 3. Current or former smokers with a smoking history of ≥10 pack-years.
✓ 4. Documented diagnosis of COPD for at least 12 months prior to enrolment
✓ 5. Moderate-to-severe COPD.
✓ 6. Documented history of ≥ 2 moderate or ≥ 1 severe COPD exacerbations within 12 months prior to enrolment.
✓ 7. Background triple therapy (ICS + LABA + LAMA) for 3 months prior to randomization with a stable dose of medication for ≥ 1 month prior to randomization; Double therapy (LABA + LAMA) allowed if ICS is contraindicated.
✓ 8. Female subjects of reproductive age (and their male partners) and male subjects (and their female partners) must use highly effective contraception throughout the study period and for at least 3 months after the last dose. The subjects had no plans to pregnancy, donate sperm or donate egg during the whole study period and for at least 3 months after the last dose.

✕ 1. Presence of a known pre-existing, clinically important lung condition other than COPD.
✕ 2. A current diagnosis of asthma or history of asthma according to the Global Initiative for Asthma (GINA) guidelines or other accepted guidelines.
✕ 3. Diagnosis of α-1 anti-trypsin deficiency.
✕ 4. Presence of an active autoimmune disease.
✕ 5. Subjects who have any malignant tumors within 5 years prior to enrollment.
✕ 6. Known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled.
✕ 7. Diagnosed active parasitic infection, suspected or high risk of parasitic infection.
✕ 8. Subjects who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.

Source: ClinicalTrials.gov · NCT07039669 · last updated 2025-11-18