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

NCT07421778 | Recruiting Phase 1

• 2 other identifiers: QRL-101-082025-524310-28-00
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Participant Study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Pharmacokinetics (plasma): 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

  Baseline through Follow up (Day 29)

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

  Baseline through Follow up (Day 29)

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

  Baseline through Follow up (Day 29)

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

  Baseline through Follow up (Day 29)

Study Arms (2)

QRL-101

EXPERIMENTAL

Drug: QRL-101

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

QRL-101 DRUG

Multiple-ascending doses of QRL-101 will be orally administered to healthy participants.

QRL-101

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• QurAlis Corporation: lead

Study Sites (1)

ICON plc.

Groningen, 9728 NZ, Netherlands

RECRUITING

Central Study Contacts

QurAlis Corporation

CONTACT

617-720-9566; clinicaltrials@quralis.com

Salah Hadi, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study will be a randomized, double-blind, placebo-controlled multiple ascending dose (MAD) study in healthy participants with the primary goal of evaluating the safety, tolerability, and PK of a novel formulation of QRL-101.

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 19, 2026
• Study Start: February 2, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

NL (1)