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Evaluation of the Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Participants With Acute Respiratory Distress Syndrome (ARDS) Associated With at Least Severe COVID-19

Acute Respiratory Distress Syndrome Clinical Trial

Official title:
A Randomized, Double-blind, Dose-ranging, Placebo Controlled, Phase 2a Evaluation of the Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Participants With Acute Respiratory Distress Syndrome (ARDS) Associated With at Least Severe COVID-19 (INTEGRIS-ARDS)

Clinical Trial Summary

Evaluation of the safety, tolerability, and pharmacokinetics of PLN-74809 in participants with acute respiratory distress syndrome (ARDS) associated with at least severe COVID-19

Clinical Trial Description

Approximately 36 participants will be enrolled sequentially into 3 cohorts. Within each cohort of 12 participants, 9 will be randomized to PLN-74809 and 3 will be randomized to placebo (3:1 ratio). - In Part 1, approximately 12 participants will be randomized to Dose level 1 of PLN-74809 or placebo QD - In Part 2, approximately 12 participants will be randomized to Dose level 2 of PLN-74809 or placebo QD - In Part 3, approximately 12 participants will be randomized to Dose level 3 of PLN-74809 or placebo QD ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04565249
Study type Interventional
Source Pliant Therapeutics, Inc.
Contact
Status Terminated
Phase Phase 2
Start date October 22, 2020
Completion date August 2, 2021
View Details
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