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To evaluate the safety, tolerability and pharmacokinetic characteristics of HSK39004 suspension for inhalation in single/multiple administration(s) in healthy subjects; to evaluate the safety,tolerability and efficacy of HSK39004 suspension for inhalation in multiple administrations in patients with Chronic Obstructive Pulmonary Disease(COPD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSK39004 in healthy volenteers | Experimental | Single or multiple inhaled HSK39004 |
|
| Placebo | Placebo Comparator | Placebo |
|
| HSK39004 in COPD patients | Experimental | multiple inhaled HSK39004 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK39004 in healthy | Drug | 1.5-12mg |
| |
| HSK39004 |
| Measure | Description | Time Frame |
|---|---|---|
| adverse events | The Incidence of adverse events as assessed by CTCAE v5.0 | From the enrollment of the subjects to 72 hours after the last administration |
| Measure | Description | Time Frame |
|---|---|---|
| AUC | area under the concentration-time curve | from 0 to 72 hours after administration |
| Cmax | maximum plasma concentration | from 0 to 72 hours after administration |
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Inclusion Criteria:
For healthy volenteers:
For COPD patients:
Exclusion Criteria:
For healthy volenteers:
For COPD patients, in addition to meeting the above exclusion criteria, they should also:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610044 | China |
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| Drug |
Placebo |
|
| HSK39004 in COPD | Drug | 1.5-6mg |
|
| t1/2 | half-life | from 0 to 72 hours after administration |
| Vz/F | apparent volume of distribution | from 0 to 72 hours after administration |
| CL/F | apparent clearance | from 0 to 72 hours after administration |
| Forced Expiratory Volume in the first second (FEV1) for patients with COPD | Mean Change From Baseline in Peak FEV1, Mean Change From Baseline FEV1 to Morning Trough FEV1 | From 0 before first administration to 24 hours after last administration |