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A Study Evaluating the Safety and Tolerability of QRL-201 in ALS

NCT05633459 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2026-05-15

No results posted yet for this study

Summary

The primary objective of this study is to determine the safety and tolerability of multiple doses of QRL-201 in people living with ALS

Conditions

Interventions

DRUG

QRL-201

QRL-201 will be intrathecally administered to all participants who enter the Open-Label Extended Dosing Period.

DRUG

Multiple ascending doses of QRL-201

Multiple ascending doses of QRL-201 will be intrathecally administered to individuals with sporadic ALS.

DRUG

Multiple ascending doses of Placebo

Multiple ascending doses of placebo comparator will be intrathecally administered to individuals with sporadic ALS.

DRUG

QRL-201

QRL-201 will be intrathecally administered to individuals with C9orf72 ALS.

DRUG

Placebo

Placebo comparator will be intrathecally administered to individuals with C9orf72 ALS.

Sponsors & Collaborators

  • QurAlis Corporation

    lead INDUSTRY

Principal Investigators

  • Manoj Malhotra, MD · QurAlis Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-16
Primary Completion
2026-05-29
Completion
2027-11-30
FDA Drug
Yes

Countries

  • Belgium
  • Canada
  • Germany
  • Ireland
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT05633459 on ClinicalTrials.gov