A Phase 1 interventional study of QRL-101 and Placebo in Healthy Participant Study, sponsored by QurAlis Corporation. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by QurAlis Corporation · Phase 1, Interventional, and Treatment
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.
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.
QurAlis Corporation is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: QRL-101
Drug: Placebo
Multiple-ascending doses of QRL-101 will be orally administered to healthy participants.
Multiple-ascending doses of comparator placebo will be administered orally to healthy participants.
Safety and tolerability
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.
Time frame: Baseline through Follow up (Day 29)
Pharmacokinetics (plasma): Area under the concentration time curve during the dosing interval (AUCτ) of QRL-101
Area under the concentration time curve during the dosing interval (AUCτ) of QRL-101
Time frame: Time Frame: Baseline through Follow up (Day 29)
Pharmacokinetics (plasma): Maximum observed concentration of QRL-101
Maximum observed concentration (Cmax) of QRL-101
Time frame: Baseline through Follow up (Day 29)
Pharmacokinetics (plasma): Time of maximum concentration of QRL-101
Time of maximum concentration (Tmax) of QRL-101
Time frame: Baseline through Follow up (Day 29)
Pharmacokinetics (plasma): Concentration of QRL-101 before the next dose
Concentration of QRL-101 reached by a drug immediately before the next dose
Time frame: Baseline through Follow up (Day 29)
Pharmacokinetics (plasma): Terminal elimination half-life of QRL-101
Terminal elimination half-life of QRL-101
Time frame: Baseline through Follow up (Day 29)
Pharmacokinetics (plasma): Area under the concentration time curve during the dosing interval (AUCτ) of QRL-101 major metabolites
Area under the concentration time curve during the dosing interval (AUCτ) of QRL-101 major metabolites
Time frame: Baseline through Follow up (Day 29)
Pharmacokinetics (plasma): Maximum observed concentration of QRL-101 major metabolites
Maximum observed concentration (Cmax) of QRL-101 major metabolites
Time frame: Baseline through Follow up (Day 29)
Pharmacokinetics (plasma): Time of maximum concentration of QRL-101 major metabolites
Time of maximum concentration (Tmax) of QRL-101 major metabolites
Time frame: Baseline through Follow up (Day 29)
Pharmacokinetics (plasma): Concentration of QRL-101 major metabolites before the next dose
Concentration of QRL-101 major metabolites reached by a drug immediately before the next dose
Time frame: Baseline through Follow up (Day 29)
Pharmacokinetics (plasma): Terminal elimination half-life of QRL-101 major metabolites
Terminal elimination half-life of QRL-101 major metabolites
Time frame: Baseline through Follow up (Day 29)
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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QurAlis Corporation