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

UK Chief Investigator

Professor Chris McDermott

Research summary

This is a first-in-human, randomised, double-blind study. This study will evaluate multiple dose levels of QRL-201, and participants will be enrolled into the study in small groups of approximately 8 participants each, called cohorts.

This study will include approximately 64 participants. The dose level of QRL-201 will increase with each group for Cohorts 1 through 6. Cohorts 7 through 8 will have the same dose level. Study drug will be administered up to 5 times to each participant over a period of approximately 3 months.

The study duration will be approximately 40 weeks: 4 weeks of screening, 12 weeks for study drug administration, 20 weeks for terminal PK collection and a final follow-up visit at 36 weeks after the first study drug administration. 

The planned study duration is 30 months from screening of the first participant until the last follow-up of the last participant.

This trial is placebo-controlled. It is important to understand what this means. Click the links to go to the glossary of terms and read  further explanations.

When considering taking part in any clinical trial, it is important to consider:
  • What the chances are of you being randomly assigned to either an intervention group or a placebo group
  • How long you would remain on this treatment allocation
  • If the study offers an open-label extension on completion of the main study.

Current status

In set-up, opening soon

Recruitment target

8 participants in the UK; up to 64 participants globally 

Recruitment group(s)

Patients with MND


Information about study sites

Contact details


Key dates

Planned recruitment opening date: April 2023

Planned recruitment end date: 30 November 2024

Inclusion / exclusion criteria

Key inclusion criteria:

Key exclusion criteria:


QurAlis Corporation 


QurAlis Corporation 

Study design

Interventional, randomised controlled trial




Outcome measures

Primary outcome measure

Secondary outcome measures