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NCT06525272

PHASE1

A Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of OsrhCT in Patients With Pleurisy

Sponsor: Healthgen Biotechnology Corp.

View on ClinicalTrials.gov

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 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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-07

Completion Date

2025-12

Last Updated

2024-07-29

Healthy Volunteers

Conditions

Pleurisy

Interventions

DRUG

Recombinant Human Chymotrypsin(OsrhCT)

Recombinant 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.

DRUG

Placebo for Recombinant Human Chymotrypsin(OsrhCT)

Placebo for Recombinant Human Chymotrypsin (OsrhCT), provided by Wuhan Healthgen Biotechnology Corporation, freeze-dried powder, stored at 2-8°C.

Inclusion Criteria: 1. Voluntary participation with signed informed consent; 2. Aged 18-65 years (inclusive), male or female; 3. Clinical diagnosis of pleurisy (parapneumonic pleural effusion, empyema, tuberculous pleurisy, etc.); 4. 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; 5. 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; 6. 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 Criteria: 1. Known allergy to the investigational drug or its excipients; 2. Known or clinically highly suspected malignant pleural effusion; 3. Received intrathoracic injection of fibrinolytic drugs (such as urokinase, streptokinase, and alteplase) within 1 month prior to enrollment; 4. History of lung resection surgery on the same side as the chest tube drainage; 5. Evidence of abdominal lesions (e.g., pancreatic cyst or renal cyst) communicating with the pleura; 6. Currently using systemic corticosteroids and unable to discontinue; 7. HIV antibody positive; 8. History of organ transplantation; 9. Severe cardiovascular, cerebrovascular, hematologic diseases, or malignancies; 10. 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; 11. Pregnant or breastfeeding women; 12. Subjects who have participated in any drug clinical trial and received treatment within the last 3 months (excluding diagnostic skin test); 13. Any other conditions deemed unsuitable for the study by the investigator.

Locations (4)

Anhui Chest Hospital

Hefei, Anhui, China

Shenzhen Third People's Hospital

Shenzhen, Guangdong, China

Wuhan Pulmonary Hospital

Wuhan, Hubei, China

Changsha Central Hospital

Changsha, Hunan, China