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

Last updated: February 12, 2025
Sponsor: QurAlis Corporation
Overall Status: Completed

Phase

1

Condition

Healthy Volunteers

Treatment

Placebo

QRL-101

Clinical Study ID

NCT06532396
QRL-101-03
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18 to 70 years of age inclusive at the time of signing the informed consent.

  2. Clinical chemistry laboratory values within acceptable range for the population, asper investigator judgment.

  3. Body mass index of 18 to 32 kg/m2 (inclusive).

  4. Willing and able to practice effective contraception.

Exclusion

Exclusion Criteria:

  1. Currently enrolled in any other clinical trial involving a study drug or off-labeluse of a drug or device, or any other type of medical research judged not to bescientifically or medically compatible with this study.

  2. Any participant in >4 studies a year and/or has participated in a clinical trialwithin 1 month of expected dosing date.

  3. History or presence of medical illness including, but not limited to, anycardiovascular, hepatic, respiratory, hematological, endocrine, psychiatric, orneurological disease, convulsions, or any clinically significant laboratoryabnormality that, in the judgment of the investigator, indicate a medical problemthat would preclude study participation.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
July 01, 2024
Estimated Completion Date:
December 20, 2024

Study Description

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.

Connect with a study center

  • ICON plc. Van Swietenlaan 6

    Groningen, 9728 NZ
    Netherlands

    Site Not Available

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