QRL-201 - Arm 1 for ALS (Amyotrophic Lateral Sclerosis)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
ALS (Amyotrophic Lateral Sclerosis)QRL-201 - Dose 7 - Drug
Eligibility
18 - 80
All Sexes
What conditions do you have?
Select

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

Eligible Conditions
  • ALS (Amyotrophic Lateral Sclerosis)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: Baseline through 253 Days

Baseline through 253 Days
Number of participants with one or more treatment emergent adverse events and serious adverse events
Hour 24
Pharmacokinetics (plasma): Area under the concentration time curve from zero to infinity (AUCinf) of QRL-201
Pharmacokinetics (plasma): Maximum observed concentration of QRL-201 (Cmax)
Pharmacokinetics (plasma): Time of maximum concentration (Tmax) of QRL-201

Trial Safety

Safety Progress

1 of 3

Trial Design

8 Treatment Groups

QRL-201 - Arm 1
1 of 8
QRL-201 - Arm 8
1 of 8
QRL-201 - Arm 3
1 of 8
QRL-201 - Arm 2
1 of 8
QRL-201 - Arm 4
1 of 8
QRL-201 - Arm 7
1 of 8
QRL-201 - Arm 5
1 of 8
QRL-201 - Arm 6
1 of 8

Experimental Treatment

64 Total Participants · 8 Treatment Groups

Primary Treatment: QRL-201 - Arm 1 · No Placebo Group · Phase 1

QRL-201 - Arm 1
Drug
Experimental Group · 1 Intervention: QRL-201 - Dose 1 · Intervention Types: Drug
QRL-201 - Arm 8
Drug
Experimental Group · 1 Intervention: QRL-201- Dose 8 · Intervention Types: Drug
QRL-201 - Arm 3
Drug
Experimental Group · 1 Intervention: QRL-201 - Dose 3 · Intervention Types: Drug
QRL-201 - Arm 2
Drug
Experimental Group · 1 Intervention: QRL-201 - Dose 2 · Intervention Types: Drug
QRL-201 - Arm 4
Drug
Experimental Group · 1 Intervention: QRL-201 - Dose 4 · Intervention Types: Drug
QRL-201 - Arm 7
Drug
Experimental Group · 1 Intervention: QRL-201 - Dose 7 · Intervention Types: Drug
QRL-201 - Arm 5
Drug
Experimental Group · 1 Intervention: QRL-201 - Dose 5 · Intervention Types: Drug
QRL-201 - Arm 6
Drug
Experimental Group · 1 Intervention: QRL-201 - Dose 6 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline through 253 days

Who is running the clinical trial?

QurAlis CorporationLead Sponsor
1 Previous Clinical Trials
40 Total Patients Enrolled
Angela Genge, MDStudy DirectorQurAlis Corporation

Eligibility Criteria

Age 18 - 80 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a male or female participant aged 18 to 80 years diagnosed with ALS.
You have slow vital capacity.
You are not pregnant or nursing.\n
You are able to tolerate a lumbar puncture.
You must be on a stable dose of the ALS drug.