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NCT05667779
A Study Evaluating Safety, Tolerability, and Pharmacokinetics of QRL-101 in Healthy Participants
Conditions: Healthy Volunteers
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: 1
Phase: PHASE1
Enrollment: 40
Sponsor: QurAlis Corporation
Location: Netherlands
Summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of ascending single doses of QRL-101 in male and female healthy participants.
Eligibility Criteria
INCLUSION CRITERIAAge 18 to 70 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.EXCLUSION CRITERIACurrently 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 subject who participates in >4 studies a year and/or has participated in a clinical trial within 1 month of 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.*Other inclusion and exclusion criteria may apply*
Source: ClinicalTrials.gov (NCT05667779). StuddyBuddy aggregates publicly available trial information.