NCT05351671

A Clinical Study to Determine the Safety, Tolerability and Effect of RLS-0071 Doses When Given to Healthy Adults After Inhaling LPS

A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Dose Range Finding Study to Assess the Safety, Tolerability, PD and PK of RLS-0071 in Healthy Adult Subjects After Challenge With Inhaled Lipopolysaccharide (LPS)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: ReAlta Life Sciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1b, randomized, double-blind, placebo-controlled, dose range finding study to assess the safety, tolerability, pharmacodynamics (PK) and pharmacokinetics (PD) of RLS-0071 in healthy adult subjects after challenge with inhaled lipopolysaccharide (LPS). Clinical data are required to determine the potential benefit of RLS-0071, a novel drug that specifically inhibits multiple inflammatory pathways, for the treatment of severe asthma. This study has been designed to evaluate the efficacy of IV administered RLS-0071 to reduce inflammation symptoms in healthy subjects challenged with inhaled LPS, a well-known agent that produces a safe and well-controlled inflammatory response in the lung. This is a critical proof-of-concept study and dose-optimization study for future studies in severe asthma patients. A total of 48 healthy adult subjects are planned to be enrolled in this study. Subjects will be randomly allocated to either of the treatment arms (Arm A or Arm B) with RLS-0071 or the placebo arm (Arm C) in a 1:1:1 ratio. Subjects will either receive intravenous infusion of RLS-0071 at a lower dose every 8 hours for a total of 3 doses (Arm A), RLS-0071 at a higher dose every 8 hours for a total of 3 doses (Arm B) or placebo dosed every 8 hours for a total of 3 doses (Arm C). Each subject completing the study will be evaluated for up to a total of 7 days. Subjects will be permitted to participate in only 1 arm of the study. Subjects discontinuing the study before data was collected at 6 hours post LPS challenge will be considered dropouts and will be replaced.

Detailed description

The inclusion of a double-blind design allows a comparison between subjects receiving RLS-0071 and placebo subjects who are experiencing the same procedures and restrictions in an unbiased manner. The inclusion of a placebo control group will facilitate the distinction between efficacy signals and possible procedural/environmental events. Eligibility criteria have been included to mitigate the risk to study subjects. Vulnerable populations such as children are excluded, as well as subjects whose medical history suggest a higher risk of experiencing adverse effects. LPS inhalation is used in this study to be able to evaluate proof-of-concept efficacy of RLS-0071 in otherwise healthy subjects. Thus, PD assessments will be conducted to provide evidence of target engagement and guide the design of future severe asthma studies.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	RLS-0071 (10 mg/kg intravenously every 8 hours for total of 3 doses)	After challenge with inhaled LPS, subjects will receive IV infusion of RLS-0071 at 10 mg/kg every 8 hours for total of 3 doses.
DRUG	RLS-0071 (loading dose of 120 mg/kg followed by 40 mg/kg every 8 hours for 2 additional doses)	After challenge with inhaled LPS, subjects will receive IV infusion of RLS-0071 at a loading dose of 120 mg/kg followed by 40 mg/kg every 8 hours for 2 additional doses.
DRUG	Placebo (saline dosed every 8 hours for a total of 3 doses)	After challenge with inhaled LPS, subjects will receive IV infusion of placebo (saline) dosed every 8 hours for a total of 3 doses.

Timeline

• Start date: 2022-05-23
• Primary completion: 2022-09-21
• Completion: 2022-09-21
• First posted: 2022-04-28
• Last updated: 2023-03-31

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated drug study