A Phase 1 Randomized, Double-Blind, Multicenter Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of OsrhCT Administered Intrathoracically in Single and Multiple Doses in Patients With Pleurisy
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 4
- 主要终点
- Safety Outcome Measures
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double (Participant,Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
- •Patients who cannot be fully drained after open drainage for ≥ 3 hours after chest tube drainage and meet the following conditions: The maximum depth of pleural effusion detected by ultrasound is ≥ 2 cm;
- •Women of childbearing potential must agree to use contraception (such as intrauterine device, contraceptive pills or condoms) during the study and within 3 months after the end of the study; men must agree to use effective contraception during the study and within 3 months after the end of study period.
排除标准
- •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;
- •Evidence of abdominal lesions (e.g., pancreatic cyst or renal cyst) communicating with the pleura;
- •Currently using systemic corticosteroids and unable to discontinue;
- •HIV antibody positive;
- •History of organ transplantation;
- •Severe cardiovascular, cerebrovascular, hematologic diseases, or malignancies;
- •Abnormal laboratory values: hemoglobin <80g/L, total bilirubin >2×ULN (upper limit of normal), ALT >2.5×ULN, AST >2.5×ULN, creatinine >2×ULN; coagulation function APTT >1.5×ULN, or INR >1.5;
- •Pregnant or breastfeeding women;
- •Subjects who have participated in any drug clinical trial and received treatment within the last 3 months (excluding diagnostic skin test);
- •Any other conditions deemed unsuitable for the study by the investigator.
研究组 & 干预措施
Recombinant Human Chymotrypsin(OsrhCT)
Recombinant Human Chymotrypsin (OsrhCT), freeze-dried powder, 4,000U/vial
Single Ascending Dose (SAD) Study:
20ml of the prepared drug will be injected into the thoracic cavity through a chest tube.There are six dose groups (2000U, 4000U, 8000U, 12000U, 16000U, 20000U),each subject can only receive administration in one dose group, and repeated administration is not allowed.
Multiple Ascending Dose (MAD) Study:
20ml of the prepared drug will be injected into the thoracic cavity through a chest tube.three dose groups (low, medium, and high) will be selected for multiple dosing. Each subject will receive only one dose group and no repeat dosing.
干预措施: Recombinant Human Chymotrypsin(OsrhCT) (Drug)
Placebo for Recombinant Human Chymotrypsin
Placebo for Recombinant Human Chymotrypsin (OsrhCT), freeze-dried powder
Single Ascending Dose (SAD) Study:
20ml of the prepared drug will be injected into the thoracic cavity through a chest tube.There are six dose groups ,each subject can only receive administration in one dose group, and repeated administration is not allowed.
Multiple Ascending Dose (MAD) Study:
20ml of the prepared drug will be injected into the thoracic cavity through a chest tube.three dose groups (low, medium, and high) will be selected for multiple dosing. Each subject will receive only one dose group and no repeat dosing.
干预措施: Placebo for Recombinant Human Chymotrypsin(OsrhCT) (Drug)
结局指标
主要结局
Safety Outcome Measures
时间窗: Single Ascending Dose (SAD) Study:7days;Multiple Ascending Dose (MAD) Study:30days
Incidence of AE
次要结局
- Efficacy Outcome Measures:Changes in pleural opacity area on chest X-ray(7 days)
- Efficacy Outcome Measures:Relative change in pleural opacity area on chest X-ray(7 days)
- Efficacy Outcome Measures:Drainage of pleural effusion(7 days)
- Efficacy Outcome Measures:Changes in inflammatory markers(7 days)