Healthy Participant Study
Conditions
Brief summary
QRL-101-08 is a multiple ascending dose (MAD) study to evaluate the safety, tolerability, and pharmacokinetics (PK) of a novel formulation of QRL-101 in healthy participants.
Detailed description
Phase 1, single-site, multiple dose study to evaluate the safety, tolerability, and PK of a novel formulation of QRL-101 in healthy participants. Up to 4 cohorts of 12 participants each, randomized 9:3 (QRL-101:placebo) will be tested. The approximate total duration of study participation for each participant may be up to 59 days.
Interventions
DRUGQRL-101
Multiple-ascending doses of QRL-101 will be orally administered to healthy participants.
DRUGPlacebo
Multiple-ascending doses of comparator placebo will be administered orally to healthy participants.
Sponsors
QurAlis Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
This study will be a randomized, double-blind, placebo-controlled multiple ascending dose (MAD) study in healthy participants with the primary goal of evaluating the safety, tolerability, and PK of a novel formulation of QRL-101.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 18 to 65 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 the 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability | Baseline through Follow up (Day 29) | Number of participants with one or more treatment emergent adverse events and serious adverse events. 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): Area under the concentration time curve during the dosing interval (AUCτ) of QRL-101 | Time Frame: Baseline through Follow up (Day 29) | Area under the concentration time curve during the dosing interval (AUCτ) of QRL-101 |
| Pharmacokinetics (plasma): Maximum observed concentration of QRL-101 | Baseline through Follow up (Day 29) | Maximum observed concentration (Cmax) of QRL-101 |
| Pharmacokinetics (plasma): Time of maximum concentration of QRL-101 | Baseline through Follow up (Day 29) | Time of maximum concentration (Tmax) of QRL-101 |
| Pharmacokinetics (plasma): Concentration of QRL-101 before the next dose | Baseline through Follow up (Day 29) | Concentration of QRL-101 reached by a drug immediately before the next dose |
| Pharmacokinetics (plasma): Terminal elimination half-life of QRL-101 | Baseline through Follow up (Day 29) | Terminal elimination half-life of QRL-101 |
| Pharmacokinetics (plasma): Area under the concentration time curve during the dosing interval (AUCτ) of QRL-101 major metabolites | Baseline through Follow up (Day 29) | Area under the concentration time curve during the dosing interval (AUCτ) of QRL-101 major metabolites |
| Pharmacokinetics (plasma): Maximum observed concentration of QRL-101 major metabolites | Baseline through Follow up (Day 29) | Maximum observed concentration (Cmax) of QRL-101 major metabolites |
| Pharmacokinetics (plasma): Time of maximum concentration of QRL-101 major metabolites | Baseline through Follow up (Day 29) | Time of maximum concentration (Tmax) of QRL-101 major metabolites |
| Pharmacokinetics (plasma): Concentration of QRL-101 major metabolites before the next dose | Baseline through Follow up (Day 29) | Concentration of QRL-101 major metabolites reached by a drug immediately before the next dose |
| Pharmacokinetics (plasma): Terminal elimination half-life of QRL-101 major metabolites | Baseline through Follow up (Day 29) | Terminal elimination half-life of QRL-101 major metabolites |
Countries
Netherlands
Outcome results
None listed