A Multiple Ascending Dose Study Evaluating the Safety and Tolerability of a Novel Formulation of … (NCT07421778) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Multiple Ascending Dose Study Evaluating the Safety and Tolerability of a Novel Formulation of QRL-101 in Healthy Participants
Netherlands48 participantsStarted 2026-02-02
Plain-language summary
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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.