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This study is open to adults with idiopathic pulmonary fibrosis who are at least 40 years old. The main objective is to evaluate of the efficacy and the secondary objective is to evaluate the safety and pharmacokinetic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSK44459-dose 1 | Experimental |
| |
| HSK44459-dose 2 | Experimental |
| |
| HSK44459-dose 3 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK44459 dose 1 | Drug | HSK44459 taken orally twice daily in the morning and in the evening for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change from baseline in forced vital capacity (FVC) at week 12 | FVC is a standard pulmonary function test used to quantify respiratory muscle weakness | day 1 and week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Relative change from baseline in FVC at week 12 | FVC is a standard pulmonary function test used to quantify respiratory muscle weakness | day 1 and week 12 |
| The change from baseline in percentage predicted forced vital capacity ( ppFVC) at week 12 |
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Inclusion Criteria:
1. Diagnosed with Idiopathic Pulmonary Fibrosis (IPF) prior to screening, patients must meet both of the following criteria:
2. Percentage Predicted Forced Vital Capacity (ppFVC) ≥45% at screening period. 3. Diffusion capacity of the lung for carbon monoxide (DLCO) (corrected for haemoglobin [Hb]) ≥ 25% of predicted normal at screening period.
4. Patients have to be either:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing Municipality | 100000 | China |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| HSK44459 dose 2 | Drug | HSK44459 taken orally twice daily in the morning and in the evening for 12 weeks. |
|
| HSK44459 dose 3 | Drug | HSK44459 taken orally twice daily in the morning and in the evening for 12 weeks. |
|
| Placebo | Drug | Placebo matching HSK44459 taken orally twice daily in the morning and in the evening for 12 weeks. |
|
FVC is a standard pulmonary function test used to quantify respiratory muscle weakness
| day 1 and week 12 |