Wuhan Healthgen Biotechnology Corp.

主要目的： 在胸膜炎患者中评价 OsrhCT经胸腔内注射单次、多次给药剂量递增的安全性、耐受性，探索OsrhCT治疗后的DLT、MTD及推荐有效剂量。 次要目的： 评价 OsrhCT经胸腔内注射单次及多次给药的初步有效性。

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.

主要目的： 评价健康受试者单次口服重组人糜蛋白酶的安全性和耐受性。 次要目的： 评价健康受试者单次口服不同剂量重组人糜蛋白酶的药代动力学特征。 探索性目的： 评价健康受试者单次口服重组人糜蛋白酶的免疫原性。