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.
Age 18 to 65 years of age inclusive at the time of signing the informed consent.
Clinical chemistry laboratory values within acceptable range for the population, as per investigator judgment.
Body mass index of 18 to 32 kg/m2 (inclusive).
Willing and able to practice effective contraception.
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.
Any participant in >4 studies a year and/or has participated in a clinical trial within 1 month of the expected dosing date.
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.
Parallel
QRL-101
DrugMultiple-ascending doses of QRL-101 will be orally administered to healthy participants.
Placebo
DrugMultiple-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.
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
Pharmacokinetics (plasma): Maximum observed concentration of QRL-101
Maximum observed concentration (Cmax) of QRL-101
Pharmacokinetics (plasma): Time of maximum concentration of QRL-101
Time of maximum concentration (Tmax) of QRL-101
Pharmacokinetics (plasma): Concentration of QRL-101 before the next dose
Concentration of QRL-101 reached by a drug immediately before the next dose
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