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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Participant Study
• Intervention / Treatment: Drug: Placebo; Drug: QRL-101

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.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: QurAlis Corporation; Phone Number: 617-720-9566; Email: clinicaltrials@quralis.com
• Study Contact Backup: Name: Salah Hadi, MD

Study Locations

• Netherlands
  • Groningen, Netherlands, 9728 NZ
    • Recruiting
    • ICON plc.
    • Contact: ICON plc.; Email: salah.hadi@iconplc.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Age 18 to 65 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 the 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
Placebo Comparator: Placebo	Drug: Placebo; Multiple-ascending doses of comparator placebo will be administered orally to healthy participants.
Experimental: QRL-101	Drug: QRL-101; Multiple-ascending doses of QRL-101 will be orally administered to healthy participants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability	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 29)

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	Time Frame: Baseline through Follow up (Day 29)
Pharmacokinetics (plasma): Maximum observed concentration of QRL-101	Maximum observed concentration (Cmax) of QRL-101	Baseline through Follow up (Day 29)
Pharmacokinetics (plasma): Time of maximum concentration of QRL-101	Time of maximum concentration (Tmax) of QRL-101	Baseline through Follow up (Day 29)
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 29)
Pharmacokinetics (plasma): Terminal elimination half-life of QRL-101	Terminal elimination half-life of QRL-101	Baseline through Follow up (Day 29)
Pharmacokinetics (plasma): Area under the concentration time curve during the dosing interval (AUCτ) of QRL-101 major metabolites	Area under the concentration time curve during the dosing interval (AUCτ) of QRL-101 major metabolites	Baseline through Follow up (Day 29)
Pharmacokinetics (plasma): Maximum observed concentration of QRL-101 major metabolites	Maximum observed concentration (Cmax) of QRL-101 major metabolites	Baseline through Follow up (Day 29)
Pharmacokinetics (plasma): Time of maximum concentration of QRL-101 major metabolites	Time of maximum concentration (Tmax) of QRL-101 major metabolites	Baseline through Follow up (Day 29)
Pharmacokinetics (plasma): Concentration of QRL-101 major metabolites before the next dose	Concentration of QRL-101 major metabolites reached by a drug immediately before the next dose	Baseline through Follow up (Day 29)
Pharmacokinetics (plasma): Terminal elimination half-life of QRL-101 major metabolites	Terminal elimination half-life of QRL-101 major metabolites	Baseline through Follow up (Day 29)

Collaborators and Investigators

• Sponsor: QurAlis Corporation

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: February 12, 2026
• First Submitted That Met QC Criteria: February 12, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: QRL-101-08; 2025-524310-28-00 (Ctis)

Drug and device information, study documents

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