A study evaluating the safety and tolerability of QRL-201 in ALS
Research type
Research Study
Full title
A multi-center, randomized, double-blind, placebo-controlled multiple ascending dose study to evaluate the safety and tolerability of QRL-201 in Amyotrophic Lateral Sclerosis
IRAS ID
1005764
Contact name
Bryan Boggs
Contact email
Sponsor organisation
QurAlis Corporation
Eudract number
2022-001606-22
Clinicaltrials.gov Identifier
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.
For participants in cohorts 1 to 4, the 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. For participants in cohorts 5 to 8, the duration of the study will be approximately 20 weeks: up to 4 weeks for screening, 12 weeks for study drug administration, and a final follow-up visit at 16 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.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
22/EE/0268
Date of REC Opinion
22 Dec 2022
REC opinion
Further Information Favourable Opinion