ALS amyotrophic lateral sclerosis
Conditions
Interventions
A single dose of QRL-101 or placebo is given on Day 1.
The volunteer will be given QRL-101 or placebo as oral capsules with 240
milliliters (mL) of (tap) water or as an oral liquid of the study com
Sponsors
QurAlis Corporation
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 to 70 years of age inclusive at the time of signing the informed consent. 2. Clinical chemistry laboratory values within acceptable range for the population, as per investigator judgment. 3. Body mass index of 18 to 32 kg/m2 (inclusive). 4. Are male or female participants, including those of childbearing potential a. Females of childbearing potential must use at least 1 highly effective method of contraception (see Table APP.3) during the trial and must have been using contraception for at least 28-days prior to the first dose of IMP and agree to use contraception during the study and after the study for at least 91 days; based on a rounding up of 5 predicted 5-hour half-lives in humans plus 90 days after the last dose of the study drug. b. Men who are sexually active must agree to use a condom, if their partner is a woman of childbearing potential. They do not need to use any contraception if: - they have had a vasectomy, and surgical success has been confirmed by medical assessment; - their partner has had a bilateral tubal ligation; or - their partner is not of childbearing potential. Men must also refrain i. from donating sperm, or ii. from unprotected sex with a female partner who is a woman of childbearing potential (WOCBP) for 91 days; based on a rounding up of 5 predicted 5-hour half-lives in humans plus 90 days after the last dose of the study drug. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Contraception requirements and definition of nonchildbearing potential are detailed in HMA CTFG Contraception guidance. 5. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion criteria
Exclusion criteria: 1. QurAlis Corporation employees, Contract Research Organization employees, investigator or site personnel directly affiliated with this study and the immediate families of either of these. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. 2. Currently enrolled in any other clinical trial involving a study drug or off-label use of a drug or device, or any other type of medical research judged not to be scientifically or medically compatible with this study. 3. Any participant in >4 studies a year and/or who has participated in a clinical trial within 1 month of expected dosing date. 4. Positive COVID-19 test, collected when required per site policy, at the Day -1 visit. 5. Answered *yes* to either Question 3, 4 or 5 on the *Suicidal Ideation* portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) and the ideation occurred within the past month; or 6. Answered *yes* to any of the suicide-related behaviors on the *Suicidal Behavior* portion of C-SSRS and the behavior occurred within the past month Further criteria apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the safety and tolerability of QRL-101 after a single oral dose in Healthy Participants | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the pharmacokinetic (PK) profile of QRL-101 after a single oral dose in Healthy Participants | — |
Countries
Netherlands
Outcome results
None listed