Pleurisy

1

Review clinical trials related to Pleurisy. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

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

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.

Participants needed: 72
Trial details
Phase: Phase 1Age: 18-65Biological sex: AllType: InterventionalSponsor: Healthgen Biotechnology Corp.Updated: Jul 29, 2024Locations: 4
Eligibility criteria

Voluntary participation with signed informed consent; [+5]

Known allergy to the investigational drug or its excipients; [+12]