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The study is being conducted to evaluate the efficacy and safety of HRS-9821 for patients with COPD, and to explore the reasonable dosage of HRS-9821 for patients with COPD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-9821 Group - Dose 1 | Experimental | HRS-9821 Inhalation Suspension, Dose 1. |
|
| HRS-9821 Group - Dose 2 | Experimental | HRS-9821 Inhalation Suspension, Dose 2. |
|
| HRS-9821 Placebo Group - Dose 1 | Placebo Comparator | HRS-9821 Placebo Inhalation Suspension, Dose 1. |
|
| HRS-9821 Placebo Group - Dose 2 | Placebo Comparator | HRS-9821 Placebo Inhalation Suspension, Dose 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-9821 Inhalation Suspension | Drug | HRS-9821 Inhalation Suspension. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in peak FEV1 (forced expiratory volume in one second) after 28 days of treatment. | From baseline to 28 days after treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in FEV1 area under the curve versus time from 0 to 12 hours (AUC0-12h) and 0 to 4 hours (AUC0-4h) after 1, 14 and 28 days of treatment. | During 28 days of treatment. | |
| Changes in peak FEV1 after 1 and 14 days of treatment. | After 1 and 14 days of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events (AEs) during the 7-week study period. | Safety outcome. | During the 7-week study period. |
| Plasma concentration of HRS-9821 after 1, 14 and 28 days of treatment. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Si Chen, M.M | Contact | +86-0518-82342973 | si.chen.sc96@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Tongji Hospital | Shanghai | Shanghai Municipality | 200065 | China |
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HRS-9821 inhalation suspension compared with placebo.
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| HRS-9821 Placebo Inhalation Suspension | Drug | HRS-9821 Placebo Inhalation Suspension. |
|
| Changes in trough FEV1 after 1, 14 and 28 days of treatment. | After 1, 14 and 28 days of treatment. |
| Changes in FVC (forced vital capacity) during 28 days of treatment. | During 28 days of treatment. |
| Changes of in SGRQ (St. George's Respiratory Questionnaire), CAT (COPD Assessment Test), mMRC (modified Medical Research Council) score during 28 days of treatment. | During 28 days of treatment. |
| The use of SABA (Short-Acting Beta₂ Agonist) during 28 days of treatment. | During 28 days of treatment. |
Pharmacokinetic outcome.
| After 1, 14 and 28 days of treatment. |
| Peak concentration after 1, 14 and 28 days of treatment. | Pharmacokinetic outcome. | After 1, 14 and 28 days of treatment. |
| Trough concentration after 1, 14 and 28 days of treatment. | Pharmacokinetic outcome. | After 1, 14 and 28 days of treatment. |
| Population Typical Clearance (CL/F) after 1, 14 and 28 days of treatment. | Pharmacokinetic outcome, population pharmacokinetic (PopPK) parameters. | After 1, 14 and 28 days of treatment. |
| Population Typical Apparent Volume of Distribution (Vd/F) after 1, 14 and 28 days of treatment. | Pharmacokinetic outcome, population pharmacokinetic (PopPK) parameters. | After 1, 14 and 28 days of treatment. |
| Changes in maximum mid-expiratory flow (MMEF) after 1, 14 and 28 days of treatment. | Exploratory outcome. | During 28 days of treatment. |
| Incidence of moderate/severe acute exacerbation of COPD (AECOPD) during 4 weeks of treatment. | Exploratory outcome. | During 4 weeks of treatment. |
| Changes in peripheral blood biomarkers (EOS, Neut, IL-6, IL-8, CRP, etc.) during 4 weeks of treatment. | Exploratory outcome. | During 4 weeks of treatment. |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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