Status:
NOT_YET_RECRUITING
A Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of OsrhCT in Patients With Pleurisy
Lead Sponsor:
Healthgen Biotechnology Corp.
Conditions:
Pleurisy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT06525272
Start Date
July 1 2024
End Date
December 1 2025
Last Update
July 29 2024
Active Locations (4)
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1
Anhui Chest Hospital
Hefei, Anhui, China, 230031
2
Shenzhen Third People's Hospital
Shenzhen, Guangdong, China, 518112
3
Wuhan Pulmonary Hospital
Wuhan, Hubei, China, 430000
4
Changsha Central Hospital
Changsha, Hunan, China, 410004