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This study is open to adults with PPF . 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 |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| HSK44459 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK44459 | Drug | HSK44459 taken orally twice daily in the morning and in the evening for 52weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change from baseline in forced vital capacity (FVC) at week 52 | FVC is a standard pulmonary function test used to quantify respiratory muscle weakness | day 1 and week 52 |
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Inclusion Criteria:
1. not on therapy with nintedanib or pirfenidone for at least 8 weeks prior to screening and during the screening period, and not planning to start or restart antiibrotic therapy.
2.on stable therapy with nintedanib or pirfenidone for at least 12 weeks prior to screening and during the screening period.
4.Percentage Predicted Forced Vital Capacity (ppFVC) ≥45% at screening period. 5.Diffusion capacity of the lung for carbon monoxide (DLCO) (corrected for haemoglobin [Hb]) ≥ 25% and <90% of predicted normal at screening period .
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sun luyin | Contact | 028-67258779 | sunluyin@haisco.com |
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| Placebo | Drug | Placebo matching HSK44459 taken orally twice daily in the morning and in the evening for 52 weeks |
|