Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06525272
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
A Study to Evaluate the Safety Tolerability and Preliminary Efficacy of OsrhCT in Patients With Pleurisy
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 4000Uvial freeze-dried powder stored at 2-8C
Placebo
Placebo for Recombinant Human Chymotrypsin OsrhCT provided by Wuhan Healthgen Biotechnology Corporation freeze-dried powder stored at 2-8C
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
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 4000Uvial freeze-dried powder stored at 2-8C
Placebo
Placebo for Recombinant Human Chymotrypsin OsrhCT provided by Wuhan Healthgen Biotechnology Corporation freeze-dried powder stored at 2-8C
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
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 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 4000Uvial freeze-dried powder stored at 2-8C
Placebo
Placebo for Recombinant Human Chymotrypsin OsrhCT provided by Wuhan Healthgen Biotechnology Corporation freeze-dried powder stored at 2-8C
Indication
Pleurisy
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
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
Single Ascending Dose SAD Study
Eligible pleurisy patients will receive a single intrathoracic injection of different doses of OsrhCT to evaluate safety and tolerability There are six dose groups 2000U 4000U 8000U 12000U 16000U 20000U If the previous dose group shows good tolerance and safety the next dose group will be enrolled
The plan is to enroll 48 subjects in this phase with 8 subjects per dose group 6 receiving intrathoracic injection of OsrhCT and 2 receiving intrathoracic injection of placebo Each subject can only receive administration in one dose group and repeated administration is not allowed
Each subject will be evaluated by the investigator based on their condition during the screening process to determine the necessity of chest tube drainage or confirm their current use of a chest tube drainage Subsequently the investigational drug will be administered into the pleural cavity following a baseline chest X-ray After administration the chest tube will be clamped for 6 hours After 6 hours the chest tube will be opened for drainage Subjects are allowed to clamp the drainage tube for sleeping or going out for examination The drainage of pleural effusion will be recorded in detail Safety checks will be performed on Day 2 and a comprehensive safety check will be performed on Day 7 Subjects will be discharged from the study if the investigator evaluates that there are no drug-related safety issues The administration of fibrinolytic agents into the pleural cavity is prohibited before Day 7
Multiple Ascending Dose MAD Study
Eligible pleurisy patients will receive multiple intrathoracic injections of different doses of OsrhCT to evaluate safety tolerability and preliminary efficacy Based on the tolerability results from the SAD study 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 If the previous dose group shows good tolerance and safety the next dose group will be enrolled
The plan is to enroll 24 subjects in this phase with 6 subjects per dose group receiving OsrhCT and 2 subjects receiving placebo Each subject will receive the drug once daily for three consecutive days
Each subject will be evaluated by the investigator based on their condition during the screening process to determine the necessity of chest tube drainage or confirm their current use of a chest tube drainage Subsequently the investigational drug will be administered into the pleural cavity following a baseline chest X-ray The drug is administered once a day for up to 3 days and the interval between the two administrations is 24h1h If pleural effusion is completely resolved before the third dose early termination of drug administration is allowed and the subject can enter the follow-up period After each administration the chest tube will be clamped for 6 hours After 6 hours the chest tube will be opened for drainage Subjects are allowed to clamp the drainage tube for sleeping or going out for examination The drainage of pleural effusion will be recorded in detail After the last dose subjects will be observed in the hospital for at least 4 days Comprehensive safety checks will be performed on Day 7 and Day 30 Subjects will be discharged from the study at Day 30 if there is no safety problem as evaluated by the investigator The administration of fibrinolytic agents into the pleural cavity is prohibited before Day 7
Dosing Plan
Investigational drug preparation Dissolve the corresponding dose of the investigational drug in 20ml of normal saline for later useAll subjects will undergo chest tube drainage before the investigational drug administration For subjects who meet the enrollment conditions 20ml of the prepared drug will be injected into the thoracic cavity through a chest tube After the injection is completed the tube will be flushed with 5ml of normal saline and then the chest tube will be clamped Subjects will be advised to change positions to ensure adequate drug contact with the pleura position changes are not mandatory
Outcome Measures
Safety Outcome Measures
AE and SAE Physical examination Vital signs Laboratory tests complete blood count blood biochemistry coagulation function and urinalysis 12-lead ECG
Efficacy Outcome Measures
Changes in pleural opacity area on chest X-ray measured as the absolute change from baseline in the percentage of pleural opacity area in the ipsilateral half of the chest on chest X-ray from pre-administration to Day 7 Relative change in pleural opacity area on chest X-ray measured as the percentage reduction of the baseline area from pre-administration to Day 7 Drainage of pleural effusion from the first administration to Day 7 Changes in inflammatory markers white blood cell count and C-reactive protein before and after treatment
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 4000Uvial freeze-dried powder stored at 2-8C
Placebo
Placebo for Recombinant Human Chymotrypsin OsrhCT provided by Wuhan Healthgen Biotechnology Corporation freeze-dried powder stored at 2-8C
Indication
Pleurisy
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
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
Single Ascending Dose SAD Study
Eligible pleurisy patients will receive a single intrathoracic injection of different doses of OsrhCT to evaluate safety and tolerability There are six dose groups 2000U 4000U 8000U 12000U 16000U 20000U If the previous dose group shows good tolerance and safety the next dose group will be enrolled
The plan is to enroll 48 subjects in this phase with 8 subjects per dose group 6 receiving intrathoracic injection of OsrhCT and 2 receiving intrathoracic injection of placebo Each subject can only receive administration in one dose group and repeated administration is not allowed
Each subject will be evaluated by the investigator based on their condition during the screening process to determine the necessity of chest tube drainage or confirm their current use of a chest tube drainage Subsequently the investigational drug will be administered into the pleural cavity following a baseline chest X-ray After administration the chest tube will be clamped for 6 hours After 6 hours the chest tube will be opened for drainage Subjects are allowed to clamp the drainage tube for sleeping or going out for examination The drainage of pleural effusion will be recorded in detail Safety checks will be performed on Day 2 and a comprehensive safety check will be performed on Day 7 Subjects will be discharged from the study if the investigator evaluates that there are no drug-related safety issues The administration of fibrinolytic agents into the pleural cavity is prohibited before Day 7
Multiple Ascending Dose MAD Study
Eligible pleurisy patients will receive multiple intrathoracic injections of different doses of OsrhCT to evaluate safety tolerability and preliminary efficacy Based on the tolerability results from the SAD study 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 If the previous dose group shows good tolerance and safety the next dose group will be enrolled
The plan is to enroll 24 subjects in this phase with 6 subjects per dose group receiving OsrhCT and 2 subjects receiving placebo Each subject will receive the drug once daily for three consecutive days
Each subject will be evaluated by the investigator based on their condition during the screening process to determine the necessity of chest tube drainage or confirm their current use of a chest tube drainage Subsequently the investigational drug will be administered into the pleural cavity following a baseline chest X-ray The drug is administered once a day for up to 3 days and the interval between the two administrations is 24h1h If pleural effusion is completely resolved before the third dose early termination of drug administration is allowed and the subject can enter the follow-up period After each administration the chest tube will be clamped for 6 hours After 6 hours the chest tube will be opened for drainage Subjects are allowed to clamp the drainage tube for sleeping or going out for examination The drainage of pleural effusion will be recorded in detail After the last dose subjects will be observed in the hospital for at least 4 days Comprehensive safety checks will be performed on Day 7 and Day 30 Subjects will be discharged from the study at Day 30 if there is no safety problem as evaluated by the investigator The administration of fibrinolytic agents into the pleural cavity is prohibited before Day 7
Dosing Plan
Investigational drug preparation Dissolve the corresponding dose of the investigational drug in 20ml of normal saline for later useAll subjects will undergo chest tube drainage before the investigational drug administration For subjects who meet the enrollment conditions 20ml of the prepared drug will be injected into the thoracic cavity through a chest tube After the injection is completed the tube will be flushed with 5ml of normal saline and then the chest tube will be clamped Subjects will be advised to change positions to ensure adequate drug contact with the pleura position changes are not mandatory
Outcome Measures
Safety Outcome Measures
AE and SAE Physical examination Vital signs Laboratory tests complete blood count blood biochemistry coagulation function and urinalysis 12-lead ECG
Efficacy Outcome Measures
Changes in pleural opacity area on chest X-ray measured as the absolute change from baseline in the percentage of pleural opacity area in the ipsilateral half of the chest on chest X-ray from pre-administration to Day 7 Relative change in pleural opacity area on chest X-ray measured as the percentage reduction of the baseline area from pre-administration to Day 7 Drainage of pleural effusion from the first administration to Day 7 Changes in inflammatory markers white blood cell count and C-reactive protein before and after treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None