A Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of OsrhCT in Patients With… (NCT06525272) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of OsrhCT in Patients With Pleurisy
China72 participantsStarted 2024-07
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Voluntary participation with signed informed consent;
✓. Aged 18-65 years (inclusive), male or female;
✓. 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 criteria
✕. Known allergy to the investigational drug or its excipients;
What they're measuring
1
Safety Outcome Measures
Timeframe: Single Ascending Dose (SAD) Study:7days;Multiple Ascending Dose (MAD) Study:30days