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Recruiting NCT07421778

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

Phase I Interventional Healthy Participant Study

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: QRL-101, Placebo.
Who it may be relevant to
Registry conditions: Healthy Participant Study. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Detailed description

Phase 1, single-site, multiple dose study to evaluate the safety, tolerability, and PK of a novel formulation of QRL-101 in healthy participants. Up to 4 cohorts of 12 participants each, randomized 9:3 (QRL-101:placebo) will be tested. The approximate total duration of study participation for each participant may be up to 59 days.

Interventions

  • Drug QRL-101
    Multiple-ascending doses of QRL-101 will be orally administered to healthy participants.
  • Drug Placebo
    Multiple-ascending doses of comparator placebo will be administered orally to healthy participants.

Primary outcome measures

  • Safety and tolerability [Time frame: Baseline through Follow up (Day 29)]
Secondary outcome measures (10)
  • Pharmacokinetics (plasma): Area under the concentration time curve during the dosing interval (AUCτ) of QRL-101 [Time frame: Time Frame: Baseline through Follow up (Day 29)]
  • Pharmacokinetics (plasma): Maximum observed concentration of QRL-101 [Time frame: Baseline through Follow up (Day 29)]
  • Pharmacokinetics (plasma): Time of maximum concentration of QRL-101 [Time frame: Baseline through Follow up (Day 29)]
  • Pharmacokinetics (plasma): Concentration of QRL-101 before the next dose [Time frame: Baseline through Follow up (Day 29)]
  • Pharmacokinetics (plasma): Terminal elimination half-life of QRL-101 [Time frame: Baseline through Follow up (Day 29)]
  • Pharmacokinetics (plasma): Area under the concentration time curve during the dosing interval (AUCτ) of QRL-101 major metabolites [Time frame: Baseline through Follow up (Day 29)]
  • Pharmacokinetics (plasma): Maximum observed concentration of QRL-101 major metabolites [Time frame: Baseline through Follow up (Day 29)]
  • Pharmacokinetics (plasma): Time of maximum concentration of QRL-101 major metabolites [Time frame: Baseline through Follow up (Day 29)]
  • Pharmacokinetics (plasma): Concentration of QRL-101 major metabolites before the next dose [Time frame: Baseline through Follow up (Day 29)]
  • Pharmacokinetics (plasma): Terminal elimination half-life of QRL-101 major metabolites [Time frame: Baseline through Follow up (Day 29)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Netherlands · 1 center
  • ICON plc. — Groningen

Identifiers

NCT: NCT07421778 · QRL-101-08 · 2025-524310-28-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗