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RecruitingPhase 1NCT07421778

A Multiple Ascending Dose Study Evaluating the Safety and Tolerability of a Novel Formulation of QRL-101 in Healthy Participants

A Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Novel Formulation of QRL-101 in Healthy Participants

Sponsor

QurAlis Corporation

Enrollment

48 participants

Start Date

Feb 2, 2026

Study Type

INTERVENTIONAL

Conditions

Healthy Participant Study

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

  • 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 Criteria3

  • 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.

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Interventions

DRUGQRL-101

Multiple-ascending doses of QRL-101 will be orally administered to healthy participants.

DRUGPlacebo

Multiple-ascending doses of comparator placebo will be administered orally to healthy participants.

Locations(1)

ICON plc.

Groningen, Netherlands

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NCT07421778

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