Primary Objectives:
To evaluate the safety and tolerability of single and multiple ascending doses of OsrhCT administered intrathoracically in patients with pleurisy, and to explore the DLT, MTD, and recommended effective dose of OsrhCT.
Secondary Objectives:
To evaluate the preliminary efficacy of single and multiple intrathoracic doses of OsrhCT.
Population:
Patients diagnosed with pleurisy requiring chest tube drainage.
Investigational Products:
Investigational Drug: Recombinant Human Chymotrypsin (OsrhCT), provided by Wuhan Healthgen Biotechnology Corporation, 4,000U/vial, freeze-dried powder, stored at 2-8°C.
Placebo:
Placebo for Recombinant Human Chymotrypsin (OsrhCT), provided by Wuhan Healthgen Biotechnology Corporation, freeze-dried powder, stored at 2-8°C.
Study Design:
The study comprises two parts: Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD), both employing a multicenter, randomized, double-blind, and placebo-controlled design.
Sample Size:
A total of 72 subjects (both male and female) are expected to be enrolled in this trial, including 48 subjects for single-dose administration and 24 subjects for multiple-dose administration.
Voluntary participation with signed informed consent;
Aged 18-65 years (inclusive), male or female;
Clinical diagnosis of pleurisy (parapneumonic pleural effusion, empyema, tuberculous pleurisy, etc.);
Patients with pleural effusion confirmed by chest ultrasound or CT examination and requiring chest tube drainage as assessed by the study physician, and the ultrasound report or CT image within one month shows that there are fibrous bands or encapsulated or septated effusions in the thoracic cavity;
Known allergy to the investigational drug or its excipients;
Known or clinically highly suspected malignant pleural effusion;
Received intrathoracic injection of fibrinolytic drugs (such as urokinase, streptokinase, and alteplase) within 1 month prior to enrollment;
History of lung resection surgery on the same side as the chest tube drainage;
Sequential
Recombinant Human Chymotrypsin(OsrhCT)
DrugRecombinant Human Chymotrypsin (OsrhCT), provided by Wuhan Healthgen Biotechnology Corporation, 4,000U/vial, freeze-dried powder, 20ml of the prepared drug will be injected into the thoracic cavity through a chest tube.
Placebo for Recombinant Human Chymotrypsin(OsrhCT)
DrugPlacebo for Recombinant Human Chymotrypsin (OsrhCT), provided by Wuhan Healthgen Biotechnology Corporation, freeze-dried powder, stored at 2-8°C.
Safety Outcome Measures
Incidence of AE
Efficacy Outcome Measures:Changes in pleural opacity area on chest X-ray
Measured as the absolute change from baseline in the percentage of pleural opacity area in the ipsilateral half of the chest on chest X-ray from pre-administration to Day 7
Efficacy Outcome Measures:Relative change in pleural opacity area on chest X-ray
Relative change in pleural opacity area on chest X-ray (measured as the percentage reduction of the baseline area from pre-administration to Day 7)
Efficacy Outcome Measures:Drainage of pleural effusion
Drainage of pleural effusion from the first administration to Day 7
Efficacy Outcome Measures:Changes in inflammatory markers
White blood cell count and C-reactive protein before and after treatment
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