HSK44459
DrugHSK44459 taken orally twice daily in the morning and in the evening for 52weeks.
NCT Number: NCT07503587
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 3
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
HSK44459 taken orally twice daily in the morning and in the evening for 52weeks.
Placebo matching HSK44459 taken orally twice daily in the morning and in the evening for 52 weeks
Time frame: day 1 and week 52
FVC is a standard pulmonary function test used to quantify respiratory muscle weakness
Contact information is provided by the study sponsor or research team.
Haisco Pharmaceutical Group Co., Ltd.
Industry
A Randomised, Double-blind, Placebo-controlled Parallel Group Phase III Clinical Study Evaluating the Efficacy and Safety of HSK44459 Tablets in Subjects With Progressive Pulmonary Fibrosis
Acronym: PPF
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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