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

NCT06525272 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2024-07-29

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Healthgen Biotechnology Corp.

    lead INDUSTRY

Principal Investigators

  • Shuihua Lu, MD · Shenzhen Third People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-31
Primary Completion
2025-07-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06525272 on ClinicalTrials.gov