NCT05298787

A Phase 1 SAD/MAD Study of RLS-0071 in Healthy Volunteers in Support of a COVID-19 Development Program

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, SAD/MAD Adaptive-Design Study to Assess the Safety, Tolerability, PK, and PD of RLS-0071 in Healthy Adult Subjects in Support of a COVID-19 Development Program

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: ReAlta Life Sciences, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, single-center, randomized, double-blind, placebo-controlled, adaptive-design study to assess the safety, tolerability, PK, and PD of single- and multiple-ascending doses of RLS-0071 in healthy adult subjects.

Detailed description

The present study is a single-ascending dose (SAD) and multiple-ascending dose (MAD) evaluation of RLS-0071 in healthy volunteers. This study is designed to evaluate the safety and tolerability of RLS-0071 administered by the intravenous (IV) route to healthy subjects as single- and multiple-ascending doses. Importantly, a SAD/MAD study in healthy subjects is critical to generate robust pharmacokinetic (PK) data using intensified PK sample collection, not feasible in a patient study.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	RLS-0071	RLS-0071 is administered as an IV infusion
DRUG	Saline Placebo	Placebo is administered as an IV infusion

Timeline

• Start date: 2021-01-13
• Primary completion: 2021-08-16
• Completion: 2021-08-16
• First posted: 2022-03-28
• Last updated: 2022-03-28

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated drug study