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

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

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).

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: QRL-101; Drug: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Groningen, Netherlands, 9728 NZ
    • ICON plc. Van Swietenlaan 6

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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, as per investigator judgment.
3. Body mass index of 18 to 32 kg/m2 (inclusive).
4. Willing and able to practice effective contraception.

Exclusion Criteria:

1. 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.
2. Any participant in >4 studies a year and/or has participated in a clinical trial within 1 month of expected dosing date.
3. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: QRL-101; Multiple-ascending doses of QRL-101 will be administered orally to healthy participants.	Drug: QRL-101; 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 Comparator: Placebo; Multiple-ascending doses of comparator placebo will be administered orally to healthy participants.	Drug: Placebo; Multiple-ascending doses of comparator placebo will be administered orally to healthy participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with one or more treatment emergent adverse events and serious adverse events.	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.	Baseline through Follow up (Day 10)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (plasma): Area under the concentration time curve during the dosing interval (AUCτ) of QRL-101	Area under the concentration time curve during the dosing interval (AUCτ) of QRL-101	Baseline through Follow up Day 5
Pharmacokinetics (plasma): Maximum observed concentration of QRL-101	Maximum observed concentration (Cmax) of QRL-101	Baseline through Follow up Day 5
Pharmacokinetics (plasma): Time of maximum concentration of QRL-101	Time of maximum concentration (Tmax) of QRL-101	Baseline through Follow up Day 5
Pharmacokinetics (plasma): Concentration of QRL-101 before the next dose	Concentration of QRL-101 reached by a drug immediately before the next dose	Baseline through Follow up Day 5
Pharmacokinetics (plasma): Terminal elimination half-life of QRL-101	Terminal elimination half-life of QRL-101	Baseline through Follow up Day 5

Collaborators and Investigators

• Sponsor: QurAlis Corporation
• Investigators: Principal Investigator: Salah Hadi, MD, ICON plc

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): December 20, 2024
• Study Completion (Actual): December 20, 2024

Study Registration Dates

• First Submitted: July 29, 2024
• First Submitted That Met QC Criteria: July 29, 2024
• First Posted (Actual): August 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 12, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Healthy Volunteers; QRL-101
• Other Study ID Numbers: QRL-101-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No