NCT04574869

A Study of RLS-0071 in Patients With Acute Lung Injury Due to COVID-19 Pneumonia in Early Respiratory Failure

A Randomized, Double-Blind, Placebo-Controlled, Two-Part Study to Evaluate the Safety, Tolerability, Preliminary Efficacy, PK, & PD of RLS-0071 in Patients With Acute Lung Injury Due to COVID-19 Pneumonia in Early Respiratory Failure

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: ReAlta Life Sciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study will test the safety, tolerability, and efficacy of RLS-0071 for approximately 28 days in comparison to a placebo control in patients with acute lung injury due to COVID-19 pneumonia in early respiratory failure. Patients will be randomized and double-blinded for two parts, a single-ascending dose (SAD) part and a multiple-ascending dose (MAD) part. The name of the study drug involved in this study is: RLS-0071.

Conditions

• Acute Lung Injury
• ALI
• COVID-19

Interventions

Type	Name	Description
DRUG	RLS-0071 10 mg/kg	Single dose IV infusion of 10 mg/kg RLS-0071
DRUG	RLS-0071 40 mg/kg	Single dose IV infusion of 40 mg/kg RLS-0071
DRUG	Placebo	The placebo control will be commercial sterile saline (0.9% Sodium Chloride Injection, United States Pharmacopoeia \[USP\]).
DRUG	RLS-0071 10 mg/kg	Multiple dose IV infusion of 10 mg/kg RLS-0071 administered every 8 hours for approximately 3 days (9 consecutive doses)
DRUG	RLS-0071 40 mg/kg	Multiple dose IV infusion of 40 mg/kg RLS-0071 administered every 8 hours for approximately 3 days (9 consecutive doses)

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-09-01
• Completion: 2022-12-01
• First posted: 2020-10-05
• Last updated: 2022-02-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study