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Safety and Preliminary Clinical Activity of Itolizumab in ARDS

Acute Respiratory Distress Syndrome Clinical Trial

Official title:
A Phase 1 Study to Evaluate the Safety, Tolerability and Preliminary Clinical Activity of Itolizumab in Subjects With Acute Respiratory Distress Syndrome Caused by Infectious Pneumonia

Clinical Trial Summary

To evaluate the safety, tolerability, PK, PD, and clinical activity of Itolizumab in subjects with acute respiratory distress syndrome (ARDS) caused by Infectious Pneumonia.

Clinical Trial Description

The study will enroll approximately 38 subjects in two parts: Part 1 is an open label 3+3 single dose escalation phase. 9-24 patients with ARDS caused by infectious pneumonia across 3 dose cohorts. Part 2 is a randomized phase and will enroll approximately 14 additional participants, randomized in a 1:1 ratio to one of the 2 doses based on efficacy data obtained from Part 1. All participants in this study will receive Itolizumab intravenously for once, investigator discretion to continue with the same dose every 3 days up to 7 days. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05978544
Study type Interventional
Source Biotech Pharmaceutical Co., Ltd.
Contact DANDAN Gao
Phone 010-51571020
Email gaodandan@biotechplc.com
Status Not yet recruiting
Phase Phase 1
Start date December 31, 2023
Completion date December 31, 2025
View Details
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