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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QRL-101 | Experimental | Multiple-ascending doses of QRL-101 will be administered orally to healthy participants. |
|
| Placebo | Placebo Comparator | Multiple-ascending doses of comparator placebo will be administered orally to healthy participants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QRL-101 | Drug | Multiple-ascending doses of QRL-101 will be orally administered. The dose levels may change subject to available nonclinical, clinical, safety, and PK data. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline through Follow up (Day 10) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (plasma): Area under the concentration time curve during the dosing interval (AUCÏ„) of QRL-101 | Area under the concentration time curve during the dosing interval (AUCÏ„) of QRL-101 | Baseline through Follow up Day 5 |
| Pharmacokinetics (plasma): Maximum observed concentration of QRL-101 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Salah Hadi, MD | ICON plc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON plc. Van Swietenlaan 6 | Groningen | 9728 NZ | Netherlands |
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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 and tolerability of QRL-101.
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A participant and investigator-blinded, randomized, placebo-controlled design will be used to minimize bias in this study.
| Placebo | Drug | Multiple-ascending doses of comparator placebo will be administered orally to healthy participants. |
|
Maximum observed concentration (Cmax) of QRL-101 |
| Baseline through Follow up Day 5 |
| Pharmacokinetics (plasma): Time of maximum concentration of QRL-101 | Time of maximum concentration (Tmax) of QRL-101 | Baseline through Follow up Day 5 |
| Pharmacokinetics (plasma): Concentration of QRL-101 before the next dose | Concentration of QRL-101 reached by a drug immediately before the next dose | Baseline through Follow up Day 5 |
| Pharmacokinetics (plasma): Terminal elimination half-life of QRL-101 | Terminal elimination half-life of QRL-101 | Baseline through Follow up Day 5 |