Healthy Volunteers
Conditions
Keywords
Healthy Volunteers
Brief summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of ascending single doses of QRL-101 in male and female healthy participants. The findings from this study will be used to inform the development of QRL-101 for people living with ALS.
Detailed description
Phase 1, single-site study to evaluate the safety, tolerability, and pharmacokinetics (PK) of ascending single doses of QRL-101 administered orally in healthy male and female participants. Up to 16 cohorts of 8 participants each, randomized 6:2 (QRL-101: placebo) will be tested. The approximate total duration of study participation for each participant may be up to 40 days.
Interventions
DRUGQRL-101
Single-ascending doses of QRL-101 will be orally administered. The dose levels may change subject to available nonclinical, clinical, safety, and PK data.
OTHERPlacebo
A placebo comparator will be administered at all dose levels.
Sponsors
QurAlis Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
A participant and investigator-blinded, randomized, placebo-controlled design will be used to minimize bias in this study.
Intervention model description
This study will be a randomized, double-blind, placebo-controlled single ascending dose (SAD) study in healthy participants with the primary goal of evaluating the safety and tolerability of QRL-101.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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. Willing and able to practice effective contraception.
Exclusion criteria
1. 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. 2. Any participant in \>4 studies a year and/or has participated in a clinical trial within 1 month of expected dosing date. 3. History or presence of medical illness including, but not limited to, any cardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric, or neurological disease, convulsions, or any clinically significant laboratory abnormality that, in the judgment of the investigator, indicate a medical problem that would preclude study participation. \*Other inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with one or more treatment emergent adverse events and serious adverse events. | Baseline through Follow up (Day 10) | Endpoints: A summary of treatment emergent adverse events (AEs), serious adverse events (SAEs), and other non-serious adverse events, regardless of causality, will be reported in the Reported Adverse Events module. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (plasma): Maximum observed concentration of QRL-101 | Baseline through Follow up (Day 10) | Endpoint: Maximum observed concentration (Cmax) of QRL-101 |
| Pharmacokinetics (plasma): Area under the concentration time curve from 0 to 24 h (AUC 0-24h) of QRL-101 | Baseline through Follow up (Day 10) | Endpoint: Area under the concentration time curve from zero to infinity (AUC 0-24h) of QRL-101 |
| Pharmacokinetics (plasma): Time of maximum concentration of QRL-101 | Baseline through Follow up (Day 10) | Endpoint: Time of maximum concentration (Tmax) of QRL-101 |
Countries
Netherlands
Outcome results
None listed