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

NCT06525272 | Not Yet Recruiting Phase 1

• 1 other identifier: HY1005-2023-2-P1
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 4

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 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.

Conditions

Pleurisy

Keywords

OsrhCT; Recombinant Human Chymotrypsin

Outcome Measures

Primary Outcomes (1)

• Safety Outcome Measures

  Incidence of AE

  Single Ascending Dose (SAD) Study:7days;Multiple Ascending Dose (MAD) Study:30days

Secondary Outcomes (4)

• 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

Study Arms (2)

Recombinant Human Chymotrypsin(OsrhCT)

EXPERIMENTAL

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.

Drug: Recombinant Human Chymotrypsin(OsrhCT)

Placebo for Recombinant Human Chymotrypsin

PLACEBO COMPARATOR

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.

Drug: Placebo for Recombinant Human Chymotrypsin(OsrhCT)

Interventions

Recombinant Human Chymotrypsin(OsrhCT) DRUG

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.

Also known as: Freeze-dried Powder of Recombinant Human Chymotrypsin(OsrhCT)

Recombinant Human Chymotrypsin(OsrhCT)

Placebo for Recombinant Human Chymotrypsin(OsrhCT) DRUG

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

Also known as: Freeze-dried Powder of Placebo for Recombinant Human Chymotrypsin(OsrhCT)

Placebo for Recombinant Human Chymotrypsin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Healthgen Biotechnology Corp.: lead

Study Sites (4)

Anhui Chest Hospital

Hefei, Anhui, 230031, China

Location

Shenzhen Third People's Hospital

Shenzhen, Guangdong, 518112, China

Location

Wuhan Pulmonary Hospital

Wuhan, Hubei, 430000, China

Location

Changsha Central Hospital

Changsha, Hunan, 410004, China

Location

MeSH Terms

Conditions

Pleurisy

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Shuihua Lu, MD

  Shenzhen Third People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuihua Lu, MD

CONTACT

+8613397122613; lushuihua66@126.com

Xuerong Chen, MD

CONTACT

+8613266782686; 384481688@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double (Participant,Investigator)
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study comprises two parts: Single Ascending Dose (SAD)，There are six dose groups (2000U, 4000U, 8000U, 12000U, 16000U, 20000U) and Multiple Ascending Dose (MAD),There are three dose groups (Low (TBD),Medium (TBD),High (TBD) ) both employing a multicenter, randomized, double-blind, and placebo-controlled design. Per dose group (6 receiving intrathoracic injection of OsrhCT and 2 receiving intrathoracic injection of placebo).

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 29, 2024
• Study Start: July 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)