NCT04565249

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

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)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Pliant Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Acute Respiratory Distress Syndrome
• SARS-CoV-2

Interventions

Type	Name	Description
DRUG	PLN-74809	PLN-74809
DRUG	Placebo	Placebo

Timeline

• Start date: 2020-10-22
• Primary completion: 2021-06-01
• Completion: 2021-08-02
• First posted: 2020-09-25
• Last updated: 2022-11-17
• Results posted: 2022-11-17

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study