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Completed

NCT Number: NCT06532396

A Study Evaluating Multiple Ascending Doses of QRL-101 in Healthy Participants

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).

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

ICON plc. Van Swietenlaan 6

Groningen, 9728 NZ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 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 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 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.

Treatment and study plan

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.

Placebo

Drug

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

Primary outcomes

  1. Number of participants with one or more treatment emergent adverse events and serious adverse events.

    Time frame: Baseline through Follow up (Day 10)

    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.

Secondary outcomes

  1. Pharmacokinetics (plasma): Area under the concentration time curve during the dosing interval (AUCτ) of QRL-101

    Time frame: Baseline through Follow up Day 5

    Area under the concentration time curve during the dosing interval (AUCτ) of QRL-101

  2. Pharmacokinetics (plasma): Maximum observed concentration of QRL-101

    Time frame: Baseline through Follow up Day 5

    Maximum observed concentration (Cmax) of QRL-101

  3. Pharmacokinetics (plasma): Time of maximum concentration of QRL-101

    Time frame: Baseline through Follow up Day 5

    Time of maximum concentration (Tmax) of QRL-101

  4. Pharmacokinetics (plasma): Concentration of QRL-101 before the next dose

    Time frame: Baseline through Follow up Day 5

    Concentration of QRL-101 reached by a drug immediately before the next dose

  5. Pharmacokinetics (plasma): Terminal elimination half-life of QRL-101

    Time frame: Baseline through Follow up Day 5

    Terminal elimination half-life of QRL-101

Sponsors and collaborators

Lead sponsor

QurAlis Corporation

Industry

Registry information

Official study title

A Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending Dose, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of QRL-101 in Healthy Participants

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 1, 2024
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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