ICON plc. Van Swietenlaan 6
Groningen, 9728 NZ, Netherlands
NCT Number: NCT06532396
QRL-101-03 is a multiple ascending dose (MAD) study to evaluate the safety, tolerability, and pharmacokinetics (PK) of QRL-101 in healthy participants. QRL-101-03 is a follow-on study to QRL-101-01, an ongoing Phase 1, single ascending dose study to determine the safety, tolerability, and PK profile of QRL-101 after a single dose (ClinicalTrials.gov ID: NCT05667779).
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Notify Me18 year–70 year
All sexes
Interventional
Phase 1
Groningen, 9728 NZ, Netherlands
Phase 1, single-site, multiple-dose study to evaluate the safety, tolerability, and PK of multiple ascending doses of QRL-101 in healthy participants. Up to 5 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 39 days.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Multiple-ascending doses of QRL-101 will be orally administered. The dose levels may change subject to available nonclinical, clinical, safety, and PK data.
Multiple-ascending doses of comparator placebo will be administered orally to healthy participants.
Time frame: Baseline through Follow up (Day 10)
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 5
Area under the concentration time curve during the dosing interval (AUCτ) of QRL-101
Time frame: Baseline through Follow up Day 5
Maximum observed concentration (Cmax) of QRL-101
Time frame: Baseline through Follow up Day 5
Time of maximum concentration (Tmax) of QRL-101
Time frame: Baseline through Follow up Day 5
Concentration of QRL-101 reached by a drug immediately before the next dose
Time frame: Baseline through Follow up Day 5
Terminal elimination half-life of QRL-101
QurAlis Corporation
Industry
A Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending Dose, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of QRL-101 in Healthy Participants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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