MedTrace Logo

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

NCT05298787 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2022-03-28

No results posted yet for this study

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.

Conditions

  • Healthy Volunteer

Interventions

DRUG

RLS-0071

RLS-0071 is administered as an IV infusion

DRUG

Saline Placebo

Placebo is administered as an IV infusion

Sponsors & Collaborators

  • ReAlta Life Sciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Kenji Cunnion, MD · Chief Medical Officer, ReAlta Life Sciences, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-13
Primary Completion
2021-08-16
Completion
2021-08-16
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05298787 on ClinicalTrials.gov